- published: 15 Apr 2024
- views: 2215
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Generic top-level domain
Generic top-level domains (gTLDs) are one of the categories of top-level domains (TLDs) maintained by the Internet Assigned Numbers Authority (IANA) for use in the Domain Name System of the Internet. A top-level domain is the last label of every fully qualified domain name. They are called generic for historic reasons; initially, they were contrasted with country-specific TLDs in RFC 920.
The core group of generic top-level domains consists of the com, info, net, and org domains. In addition, the domains biz, name, and pro are also considered generic; however, these are designated as restricted, because registrations within them require proof of eligibility within the guidelines set for each.
Historically, the group of generic top-level domains included domains, created in the early development of the domain name system, that are now sponsored by designated agencies or organizations and are restricted to specific types of registrants. Thus, domains edu, gov, int, and mil are now considered sponsored top-level domains, much like the themed top-level domains (e.g., jobs). The entire group of domains that do not have a geographic or country designation (see country-code top-level domain) is still often referred to by the term generic TLDs.
This page contains text from Wikipedia, the Free Encyclopedia - https://wn.com/Generic_top-level_domain
Rugby league positions
A rugby league football team consists of thirteen players on the field, with four substitutes on the bench. Players are divided into two general categories, forwards and backs.
Forwards are generally chosen for their size and strength. They are expected to run with the ball, to attack, and to make tackles. Forwards are required to improve the team's field position thus creating space and time for the backs. Backs are usually smaller and faster, though a big, fast player can be of advantage in the backs. Their roles require speed and ball-playing skills, rather than just strength, to take advantage of the field position gained by the forwards.
Names and numbering
The laws of the game recognise standardised numbering of positions. The starting side normally wear the numbers corresponding to their positions, only changing in the case of substitutions and position shifts during the game. In some competitions, such as Super League, players receive a squad number to use all season, no matter what positions they play in.
This page contains text from Wikipedia, the Free Encyclopedia - https://wn.com/Rugby_league_positions
Center (basketball)
The center (C), also known as the five or the big man, is one of the five positions in a regulation basketball game. The center is normally the tallest player on the team, and often has a great deal of strength and body mass as well.
The tallest player to ever be drafted in the NBA or the WNBA was the 7'8" (2.33 m) Yasutaka Okayama from Japan, though he never played in the NBA. The tallest players to ever play in the NBA, at 7'7" (2.31 m), are centers Gheorghe Mureșan, and Manute Bol. Standing at 7'2" (2.18 m), Margo Dydek is the tallest player to have ever played in the WNBA.
History of the center position
Emergence of the center and the era of George Mikan
The center is considered a necessary component for a successful team, especially in professional leagues such as the NBA. Great centers have been the foundation for most of the dynasties in both the NBA and NCAA. The 6’10" (2.08 m) George Mikan pioneered the Center position, shattering the widely held perception that tall players could not develop the agility and coordination to play basketball well, and ushering in the role of the dominant big man. He led DePaul University to the NIT title, then, after turning professional, won seven National Basketball League, Basketball Association of America and NBA Championships in his ten-year career (1946–56), nine of them with the Minneapolis Lakers. Using his height to dominate opposing players, Mikan invented the hook shot and the shot block; as a consequence, the NCAA, and later NBA, adopted the goaltending rule, and, in 1951, the NBA widened the foul lane, a decision known as the 'Mikan rule'.
This page contains text from Wikipedia, the Free Encyclopedia - https://wn.com/Center_(basketball)
Podcasts:
-
Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI)
C3TI will serve as a hub for trial sponsors, CDER staff, and the public to immerse themselves in clinical trial innovation and to adopt new approaches in a way that is embedded in the drug development and the review process. Learn more at www.fda.gov/C3TI
published: 15 Apr 2024 -
Many just need an opportunity: Join FDA’s Center for Drug Evaluation and Research (CDER)
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain why you could be eligible for the Center’s many fellowship programs.
published: 20 Dec 2016 -
Presentation 16 - The FDA and Center for Drug Evaluation Research (CDER) - Anne Zajicek
This lecture is part of the NIH Clinical and Translational Research Summer Course which provides an online opportunity for didactic learning through lectures, discussions, and small group activities. The course also provides an opportunity to learn more about the unique resources available at the NIH, to meet with researchers and program administrators, and to learn more about potential career opportunities at the NIH. If you have any questions or need additional information regarding the Clinical and Translational Research Summer Course, please email the course coordinator at: [email protected].
published: 26 Jun 2023 -
Looking for the best and the brightest to join FDA’s Center for Drug Evaluation and Research
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain the career opportunities available to professionals and recent college graduates at FDA’s Center for Drug Evaluation and Research.
published: 05 May 2022 -
Center for Drug Evaluation
published: 03 Nov 2016 -
What can CDER do for you? (3of15) REdI Annual Conference – May 29-30, 2019
CDER Deputy Director for Regulatory Programs Douglas C. Throckmorton, MD, provides an overview of CDER’s role in drug development and regulation, discusses the importance of small businesses in drug development, and CDER support for small businesses. Learn more at https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/regulatory-education-industry-redi-annual-conference-may-29-30-2019 _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities. Email: [email protected] Phone: (301) 796-6707 I (866) 405-...
published: 27 Mar 2020 -
How FDA is Using "Organ on a Chip" Technology to Improve Drug Evaluation Research | Researching FDA
Scientists at FDA are using organ on a chip models to improve drug development. Learn more about organ chips here: https://www.fda.gov/files/food/published/Organs-On-Chips-Technology-Infographic.pdf We're taking you on a journey into the heart of regulatory science, where innovation meets safety, and research drives policy decisions. At FDA, we're committed to advancing science for the benefit of society, and this series will showcase our groundbreaking work in the realm of regulatory science. 🔬 What is Regulatory Science? Regulatory science is the art and science of developing and evaluating tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. From pharmaceuticals and medical devices to food and cosmetics, our agency plays...
published: 22 May 2024 -
Division of Applied Regulatory Science in FDA’s Center for Drug Evaluation and Research
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain you want to be a computational scientist in FDA’s Center for Evaluation and Research.
published: 20 Dec 2016 -
How does the FDA approve new drugs? (30 seconds)
Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).
published: 09 Aug 2024 -
The FDA's Center for Drug Evaluation & Research: Gatekeepers of Drug Safety & Efficacy in the U.S.
Author: Dr. #PooyanGhamari, Swiss Visionary Introduction: The United States Food and Drug Administration (FDA) is the principal federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, biological products, and medical devices. Within the FDA, the Center for Drug Evaluation and Research (CDER) functions as the sentinel, overseeing the new drug approval process. This process is a cornerstone of the healthcare system in the U.S., embodying a comprehensive review system designed to ensure that all new pharmaceuticals meet the highest standards of safety and therapeutic efficacy before reaching the consumer. The CDER’s Role in New Drug Approval: The journey of a new drug from laboratory to pharmacy shelves is an intricate and methodical process. C...
published: 08 Nov 2023
developed with YouTube
3:00
Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI)
- Order: Reorder
- Duration: 3:00
- Uploaded Date: 15 Apr 2024
- views: 2215
C3TI will serve as a hub for trial sponsors, CDER staff, and the public to immerse themselves in clinical trial innovation and to adopt new approaches in a wa...
C3TI will serve as a hub for trial sponsors, CDER staff, and the public to immerse themselves in clinical trial innovation and to adopt new approaches in a way that is embedded in the drug development and the review process. Learn more at www.fda.gov/C3TI
https://wn.com/Center_For_Drug_Evaluation_And_Research_(Cder)_Center_For_Clinical_Trial_Innovation_(C3Ti)
C3TI will serve as a hub for trial sponsors, CDER staff, and the public to immerse themselves in clinical trial innovation and to adopt new approaches in a way that is embedded in the drug development and the review process. Learn more at www.fda.gov/C3TI
3:40
Many just need an opportunity: Join FDA’s Center for Drug Evaluation and Research (CDER)
- Order: Reorder
- Duration: 3:40
- Uploaded Date: 20 Dec 2016
- views: 15611
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for...
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain why you could be eligible for the Center’s many fellowship programs.
https://wn.com/Many_Just_Need_An_Opportunity_Join_Fda’S_Center_For_Drug_Evaluation_And_Research_(Cder)
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain why you could be eligible for the Center’s many fellowship programs.
- published: 20 Dec 2016
- views: 15611
20:42
Presentation 16 - The FDA and Center for Drug Evaluation Research (CDER) - Anne Zajicek
- Order: Reorder
- Duration: 20:42
- Uploaded Date: 26 Jun 2023
- views: 284
This lecture is part of the NIH Clinical and Translational Research Summer Course which provides an online opportunity for didactic learning through lectures, d...
This lecture is part of the NIH Clinical and Translational Research Summer Course which provides an online opportunity for didactic learning through lectures, discussions, and small group activities. The course also provides an opportunity to learn more about the unique resources available at the NIH, to meet with researchers and program administrators, and to learn more about potential career opportunities at the NIH. If you have any questions or need additional information regarding the Clinical and Translational Research Summer Course, please email the course coordinator at: [email protected].
https://wn.com/Presentation_16_The_Fda_And_Center_For_Drug_Evaluation_Research_(Cder)_Anne_Zajicek
This lecture is part of the NIH Clinical and Translational Research Summer Course which provides an online opportunity for didactic learning through lectures, discussions, and small group activities. The course also provides an opportunity to learn more about the unique resources available at the NIH, to meet with researchers and program administrators, and to learn more about potential career opportunities at the NIH. If you have any questions or need additional information regarding the Clinical and Translational Research Summer Course, please email the course coordinator at: [email protected].
- published: 26 Jun 2023
- views: 284
2:42
Looking for the best and the brightest to join FDA’s Center for Drug Evaluation and Research
- Order: Reorder
- Duration: 2:42
- Uploaded Date: 05 May 2022
- views: 3526
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for...
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain the career opportunities available to professionals and recent college graduates at FDA’s Center for Drug Evaluation and Research.
https://wn.com/Looking_For_The_Best_And_The_Brightest_To_Join_Fda’S_Center_For_Drug_Evaluation_And_Research
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain the career opportunities available to professionals and recent college graduates at FDA’s Center for Drug Evaluation and Research.
- published: 05 May 2022
- views: 3526
6:21
Center for Drug Evaluation
- Order: Reorder
- Duration: 6:21
- Uploaded Date: 03 Nov 2016
- views: 475
- published: 03 Nov 2016
- views: 475
36:06
What can CDER do for you? (3of15) REdI Annual Conference – May 29-30, 2019
- Order: Reorder
- Duration: 36:06
- Uploaded Date: 27 Mar 2020
- views: 1706
CDER Deputy Director for Regulatory Programs Douglas C. Throckmorton, MD, provides an overview of CDER’s role in drug development and regulation, discusses the ...
CDER Deputy Director for Regulatory Programs Douglas C. Throckmorton, MD, provides an overview of CDER’s role in drug development and regulation, discusses the importance of small businesses in drug development, and CDER support for small businesses.
Learn more at https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/regulatory-education-industry-redi-annual-conference-may-29-30-2019
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.
Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
Twitter: https://twitter.com/FDA_Drug_Info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionmanagement
https://wn.com/What_Can_Cder_Do_For_You_(3Of15)_Redi_Annual_Conference_–_May_29_30,_2019
CDER Deputy Director for Regulatory Programs Douglas C. Throckmorton, MD, provides an overview of CDER’s role in drug development and regulation, discusses the importance of small businesses in drug development, and CDER support for small businesses.
Learn more at https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/regulatory-education-industry-redi-annual-conference-may-29-30-2019
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.
Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
Twitter: https://twitter.com/FDA_Drug_Info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionmanagement
- published: 27 Mar 2020
- views: 1706
0:13
How FDA is Using "Organ on a Chip" Technology to Improve Drug Evaluation Research | Researching FDA
- Order: Reorder
- Duration: 0:13
- Uploaded Date: 22 May 2024
- views: 3061
Scientists at FDA are using organ on a chip models to improve drug development. Learn more about organ chips here: https://www.fda.gov/files/food/published/Orga...
Scientists at FDA are using organ on a chip models to improve drug development. Learn more about organ chips here: https://www.fda.gov/files/food/published/Organs-On-Chips-Technology-Infographic.pdf
We're taking you on a journey into the heart of regulatory science, where innovation meets safety, and research drives policy decisions. At FDA, we're committed to advancing science for the benefit of society, and this series will showcase our groundbreaking work in the realm of regulatory science.
🔬 What is Regulatory Science? Regulatory science is the art and science of developing and evaluating tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. From pharmaceuticals and medical devices to food and cosmetics, our agency plays a pivotal role in ensuring your safety and well-being.
Join us in this educational and informative series as we share our mission, achievements, and commitment to public health. Whether you're a scientist, a healthcare professional, a student, or simply curious about the world of regulatory science, there's something here for everyone.
Don't forget to subscribe to our channel, hit the notification bell, and stay tuned for weekly episodes that will keep you informed and inspired. Together, we're shaping the future of regulatory science!
Thank you for joining us on this remarkable journey through the world of regulatory science. Together, we'll unravel the mysteries of science and make the world a safer place. Stay tuned, and let's explore the future of healthcare and consumer protection together! 🌟🔬🌎 #RegulatoryScience #FDAknowledge #ScienceForSafety #ResearchingFDA
https://wn.com/How_Fda_Is_Using_Organ_On_A_Chip_Technology_To_Improve_Drug_Evaluation_Research_|_Researching_Fda
Scientists at FDA are using organ on a chip models to improve drug development. Learn more about organ chips here: https://www.fda.gov/files/food/published/Organs-On-Chips-Technology-Infographic.pdf
We're taking you on a journey into the heart of regulatory science, where innovation meets safety, and research drives policy decisions. At FDA, we're committed to advancing science for the benefit of society, and this series will showcase our groundbreaking work in the realm of regulatory science.
🔬 What is Regulatory Science? Regulatory science is the art and science of developing and evaluating tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. From pharmaceuticals and medical devices to food and cosmetics, our agency plays a pivotal role in ensuring your safety and well-being.
Join us in this educational and informative series as we share our mission, achievements, and commitment to public health. Whether you're a scientist, a healthcare professional, a student, or simply curious about the world of regulatory science, there's something here for everyone.
Don't forget to subscribe to our channel, hit the notification bell, and stay tuned for weekly episodes that will keep you informed and inspired. Together, we're shaping the future of regulatory science!
Thank you for joining us on this remarkable journey through the world of regulatory science. Together, we'll unravel the mysteries of science and make the world a safer place. Stay tuned, and let's explore the future of healthcare and consumer protection together! 🌟🔬🌎 #RegulatoryScience #FDAknowledge #ScienceForSafety #ResearchingFDA
- published: 22 May 2024
- views: 3061
3:31
Division of Applied Regulatory Science in FDA’s Center for Drug Evaluation and Research
- Order: Reorder
- Duration: 3:31
- Uploaded Date: 20 Dec 2016
- views: 2172
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for...
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain you want to be a computational scientist in FDA’s Center for Evaluation and Research.
https://wn.com/Division_Of_Applied_Regulatory_Science_In_Fda’S_Center_For_Drug_Evaluation_And_Research
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain you want to be a computational scientist in FDA’s Center for Evaluation and Research.
- published: 20 Dec 2016
- views: 2172
0:30
How does the FDA approve new drugs? (30 seconds)
- Order: Reorder
- Duration: 0:30
- Uploaded Date: 09 Aug 2024
- views: 510557
Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from ...
Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).
https://wn.com/How_Does_The_Fda_Approve_New_Drugs_(30_Seconds)
Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).
- published: 09 Aug 2024
- views: 510557
5:50
The FDA's Center for Drug Evaluation & Research: Gatekeepers of Drug Safety & Efficacy in the U.S.
- Order: Reorder
- Duration: 5:50
- Uploaded Date: 08 Nov 2023
- views: 159
Author: Dr. #PooyanGhamari, Swiss Visionary
Introduction:
The United States Food and Drug Administration (FDA) is the principal federal agency responsible for ...
Author: Dr. #PooyanGhamari, Swiss Visionary
Introduction:
The United States Food and Drug Administration (FDA) is the principal federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, biological products, and medical devices. Within the FDA, the Center for Drug Evaluation and Research (CDER) functions as the sentinel, overseeing the new drug approval process.
This process is a cornerstone of the healthcare system in the U.S., embodying a comprehensive review system designed to ensure that all new pharmaceuticals meet the highest standards of safety and therapeutic efficacy before reaching the consumer.
The CDER’s Role in New Drug Approval:
The journey of a new drug from laboratory to pharmacy shelves is an intricate and methodical process. CDER's charge is to meticulously evaluate the full spectrum of a drug's lifecycle. This journey begins with the submission of an Investigational New Drug application (IND), where pharmaceutical companies provide preclinical data to justify proceeding to human trials.
Following the IND, a series of clinical trials are conducted, and results are submitted to the FDA in the form of a New Drug Application (NDA). The NDA is a comprehensive document that includes all proprietary information about the drug, including its chemical composition, its mechanism of action, manufacturing processes, pharmacokinetics, pharmacodynamics, and all data from the preclinical and clinical trials.
The Rigorous Review Process:
CDER's review process is meticulous and multidisciplinary, involving a team of physicians, statisticians, chemists, pharmacologists, and other scientific experts. This team scrutinizes every detail of the NDA to confirm that:
- The drug's proposed labeling is appropriate and includes all necessary information for the safe and effective use of the drug.
- The drug is manufactured in accordance with GMP to ensure its identity, strength, quality, and purity.
- The clinical trial data are robust and demonstrate the drug's efficacy for its intended use.
- The benefits of the drug outweigh the risks, considering the condition it is designed to treat and the patient population intended to use it.
This scrutiny extends to the evaluation of the raw data from clinical trials, not just the summaries provided by the pharmaceutical companies. FDA reviewers must be convinced that the studies were conducted ethically and that the data support the conclusions drawn.
Balancing Benefits and Risks:
One of the critical aspects of the drug approval process is the assessment of the risk-benefit balance. The CDER does not require that a drug be completely free of risk but demands a favorable risk-benefit ratio. This means that the expected therapeutic benefits must justify any potential risks associated with the drug’s use.
Ongoing Monitoring and Post-Marketing Surveillance:
The CDER's responsibility does not end with drug approval. The center engages in continual post-marketing surveillance to monitor drugs' performance in real-world settings. It oversees the implementation of Risk Evaluation and Mitigation Strategies (REMS), when necessary, to manage known or potential risks associated with a drug. Additionally, the CDER monitors adverse event reports and can require further post-marketing studies to address any emerging safety concerns.
Conclusion:
The FDA's CDER embodies the rigorous scientific and regulatory expertise required to ensure that new medicinal products entering the U.S. market are safe and effective. The meticulous approval process, along with ongoing post-market analysis, underlines a dedication to protecting American patients and reinforces the integrity of the pharmaceutical industry.
In an era where medical advancements are accelerating, Dr. Pooyan Ghamari highlights the indispensability of an agency like the CDER, which serves as the critical interface between pharmaceutical innovation and patient safety.
Its commitment to stringent regulatory scrutiny ensures that the American public can access therapeutic innovations with confidence in their safety and efficacy. The work of the CDER is thus not just regulatory in nature; it is a profound responsibility carried out with scientific rigor and a dedication to public health.
https://wn.com/The_Fda's_Center_For_Drug_Evaluation_Research_Gatekeepers_Of_Drug_Safety_Efficacy_In_The_U.S.
Author: Dr. #PooyanGhamari, Swiss Visionary
Introduction:
The United States Food and Drug Administration (FDA) is the principal federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, biological products, and medical devices. Within the FDA, the Center for Drug Evaluation and Research (CDER) functions as the sentinel, overseeing the new drug approval process.
This process is a cornerstone of the healthcare system in the U.S., embodying a comprehensive review system designed to ensure that all new pharmaceuticals meet the highest standards of safety and therapeutic efficacy before reaching the consumer.
The CDER’s Role in New Drug Approval:
The journey of a new drug from laboratory to pharmacy shelves is an intricate and methodical process. CDER's charge is to meticulously evaluate the full spectrum of a drug's lifecycle. This journey begins with the submission of an Investigational New Drug application (IND), where pharmaceutical companies provide preclinical data to justify proceeding to human trials.
Following the IND, a series of clinical trials are conducted, and results are submitted to the FDA in the form of a New Drug Application (NDA). The NDA is a comprehensive document that includes all proprietary information about the drug, including its chemical composition, its mechanism of action, manufacturing processes, pharmacokinetics, pharmacodynamics, and all data from the preclinical and clinical trials.
The Rigorous Review Process:
CDER's review process is meticulous and multidisciplinary, involving a team of physicians, statisticians, chemists, pharmacologists, and other scientific experts. This team scrutinizes every detail of the NDA to confirm that:
- The drug's proposed labeling is appropriate and includes all necessary information for the safe and effective use of the drug.
- The drug is manufactured in accordance with GMP to ensure its identity, strength, quality, and purity.
- The clinical trial data are robust and demonstrate the drug's efficacy for its intended use.
- The benefits of the drug outweigh the risks, considering the condition it is designed to treat and the patient population intended to use it.
This scrutiny extends to the evaluation of the raw data from clinical trials, not just the summaries provided by the pharmaceutical companies. FDA reviewers must be convinced that the studies were conducted ethically and that the data support the conclusions drawn.
Balancing Benefits and Risks:
One of the critical aspects of the drug approval process is the assessment of the risk-benefit balance. The CDER does not require that a drug be completely free of risk but demands a favorable risk-benefit ratio. This means that the expected therapeutic benefits must justify any potential risks associated with the drug’s use.
Ongoing Monitoring and Post-Marketing Surveillance:
The CDER's responsibility does not end with drug approval. The center engages in continual post-marketing surveillance to monitor drugs' performance in real-world settings. It oversees the implementation of Risk Evaluation and Mitigation Strategies (REMS), when necessary, to manage known or potential risks associated with a drug. Additionally, the CDER monitors adverse event reports and can require further post-marketing studies to address any emerging safety concerns.
Conclusion:
The FDA's CDER embodies the rigorous scientific and regulatory expertise required to ensure that new medicinal products entering the U.S. market are safe and effective. The meticulous approval process, along with ongoing post-market analysis, underlines a dedication to protecting American patients and reinforces the integrity of the pharmaceutical industry.
In an era where medical advancements are accelerating, Dr. Pooyan Ghamari highlights the indispensability of an agency like the CDER, which serves as the critical interface between pharmaceutical innovation and patient safety.
Its commitment to stringent regulatory scrutiny ensures that the American public can access therapeutic innovations with confidence in their safety and efficacy. The work of the CDER is thus not just regulatory in nature; it is a profound responsibility carried out with scientific rigor and a dedication to public health.
- published: 08 Nov 2023
- views: 159
3:00
Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI)
C3TI will serve as a hub for trial sponsors, CDER staff, and the public to immerse thems...
published: 15 Apr 2024
Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI)
Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI)
- Report rights infringement
- published: 15 Apr 2024
- views: 2215
C3TI will serve as a hub for trial sponsors, CDER staff, and the public to immerse themselves in clinical trial innovation and to adopt new approaches in a way that is embedded in the drug development and the review process. Learn more at www.fda.gov/C3TI
3:40
Many just need an opportunity: Join FDA’s Center for Drug Evaluation and Research (CDER)
An upbeat, creative, and informative overview that outlines the advantages of working at ...
published: 20 Dec 2016
Many just need an opportunity: Join FDA’s Center for Drug Evaluation and Research (CDER)
Many just need an opportunity: Join FDA’s Center for Drug Evaluation and Research (CDER)
- Report rights infringement
- published: 20 Dec 2016
- views: 15611
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain why you could be eligible for the Center’s many fellowship programs.
20:42
Presentation 16 - The FDA and Center for Drug Evaluation Research (CDER) - Anne Zajicek
This lecture is part of the NIH Clinical and Translational Research Summer Course which pr...
published: 26 Jun 2023
Presentation 16 - The FDA and Center for Drug Evaluation Research (CDER) - Anne Zajicek
Presentation 16 - The FDA and Center for Drug Evaluation Research (CDER) - Anne Zajicek
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- published: 26 Jun 2023
- views: 284
This lecture is part of the NIH Clinical and Translational Research Summer Course which provides an online opportunity for didactic learning through lectures, discussions, and small group activities. The course also provides an opportunity to learn more about the unique resources available at the NIH, to meet with researchers and program administrators, and to learn more about potential career opportunities at the NIH. If you have any questions or need additional information regarding the Clinical and Translational Research Summer Course, please email the course coordinator at: [email protected].
2:42
Looking for the best and the brightest to join FDA’s Center for Drug Evaluation and Research
An upbeat, creative, and informative overview that outlines the advantages of working at ...
published: 05 May 2022
Looking for the best and the brightest to join FDA’s Center for Drug Evaluation and Research
Looking for the best and the brightest to join FDA’s Center for Drug Evaluation and Research
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- published: 05 May 2022
- views: 3526
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain the career opportunities available to professionals and recent college graduates at FDA’s Center for Drug Evaluation and Research.
6:21
Center for Drug Evaluation
published: 03 Nov 2016
Center for Drug Evaluation
36:06
What can CDER do for you? (3of15) REdI Annual Conference – May 29-30, 2019
CDER Deputy Director for Regulatory Programs Douglas C. Throckmorton, MD, provides an over...
published: 27 Mar 2020
What can CDER do for you? (3of15) REdI Annual Conference – May 29-30, 2019
What can CDER do for you? (3of15) REdI Annual Conference – May 29-30, 2019
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- published: 27 Mar 2020
- views: 1706
CDER Deputy Director for Regulatory Programs Douglas C. Throckmorton, MD, provides an overview of CDER’s role in drug development and regulation, discusses the importance of small businesses in drug development, and CDER support for small businesses.
Learn more at https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/regulatory-education-industry-redi-annual-conference-may-29-30-2019
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.
Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
Twitter: https://twitter.com/FDA_Drug_Info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionmanagement
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How FDA is Using "Organ on a Chip" Technology to Improve Drug Evaluation Research | Researching FDA
Scientists at FDA are using organ on a chip models to improve drug development. Learn more...
published: 22 May 2024
How FDA is Using "Organ on a Chip" Technology to Improve Drug Evaluation Research | Researching FDA
How FDA is Using "Organ on a Chip" Technology to Improve Drug Evaluation Research | Researching FDA
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- published: 22 May 2024
- views: 3061
Scientists at FDA are using organ on a chip models to improve drug development. Learn more about organ chips here: https://www.fda.gov/files/food/published/Organs-On-Chips-Technology-Infographic.pdf
We're taking you on a journey into the heart of regulatory science, where innovation meets safety, and research drives policy decisions. At FDA, we're committed to advancing science for the benefit of society, and this series will showcase our groundbreaking work in the realm of regulatory science.
🔬 What is Regulatory Science? Regulatory science is the art and science of developing and evaluating tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. From pharmaceuticals and medical devices to food and cosmetics, our agency plays a pivotal role in ensuring your safety and well-being.
Join us in this educational and informative series as we share our mission, achievements, and commitment to public health. Whether you're a scientist, a healthcare professional, a student, or simply curious about the world of regulatory science, there's something here for everyone.
Don't forget to subscribe to our channel, hit the notification bell, and stay tuned for weekly episodes that will keep you informed and inspired. Together, we're shaping the future of regulatory science!
Thank you for joining us on this remarkable journey through the world of regulatory science. Together, we'll unravel the mysteries of science and make the world a safer place. Stay tuned, and let's explore the future of healthcare and consumer protection together! 🌟🔬🌎 #RegulatoryScience #FDAknowledge #ScienceForSafety #ResearchingFDA
3:31
Division of Applied Regulatory Science in FDA’s Center for Drug Evaluation and Research
An upbeat, creative, and informative overview that outlines the advantages of working at ...
published: 20 Dec 2016
Division of Applied Regulatory Science in FDA’s Center for Drug Evaluation and Research
Division of Applied Regulatory Science in FDA’s Center for Drug Evaluation and Research
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- published: 20 Dec 2016
- views: 2172
An upbeat, creative, and informative overview that outlines the advantages of working at the FDA’s Center for Drug Evaluation and Research. There is a need for CDER to continue to attract highly-qualified and diverse candidates for employment at the federal government agency that regulates prescription and over-the-counter drug development. Let us explain you want to be a computational scientist in FDA’s Center for Evaluation and Research.
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How does the FDA approve new drugs? (30 seconds)
Prescription drugs go through many steps and phases before they’re approved by the FDA, fr...
published: 09 Aug 2024
How does the FDA approve new drugs? (30 seconds)
How does the FDA approve new drugs? (30 seconds)
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- published: 09 Aug 2024
- views: 510557
Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).
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The FDA's Center for Drug Evaluation & Research: Gatekeepers of Drug Safety & Efficacy in the U.S.
Author: Dr. #PooyanGhamari, Swiss Visionary
Introduction:
The United States Food and Drug...
published: 08 Nov 2023
The FDA's Center for Drug Evaluation & Research: Gatekeepers of Drug Safety & Efficacy in the U.S.
The FDA's Center for Drug Evaluation & Research: Gatekeepers of Drug Safety & Efficacy in the U.S.
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- published: 08 Nov 2023
- views: 159
Author: Dr. #PooyanGhamari, Swiss Visionary
Introduction:
The United States Food and Drug Administration (FDA) is the principal federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, biological products, and medical devices. Within the FDA, the Center for Drug Evaluation and Research (CDER) functions as the sentinel, overseeing the new drug approval process.
This process is a cornerstone of the healthcare system in the U.S., embodying a comprehensive review system designed to ensure that all new pharmaceuticals meet the highest standards of safety and therapeutic efficacy before reaching the consumer.
The CDER’s Role in New Drug Approval:
The journey of a new drug from laboratory to pharmacy shelves is an intricate and methodical process. CDER's charge is to meticulously evaluate the full spectrum of a drug's lifecycle. This journey begins with the submission of an Investigational New Drug application (IND), where pharmaceutical companies provide preclinical data to justify proceeding to human trials.
Following the IND, a series of clinical trials are conducted, and results are submitted to the FDA in the form of a New Drug Application (NDA). The NDA is a comprehensive document that includes all proprietary information about the drug, including its chemical composition, its mechanism of action, manufacturing processes, pharmacokinetics, pharmacodynamics, and all data from the preclinical and clinical trials.
The Rigorous Review Process:
CDER's review process is meticulous and multidisciplinary, involving a team of physicians, statisticians, chemists, pharmacologists, and other scientific experts. This team scrutinizes every detail of the NDA to confirm that:
- The drug's proposed labeling is appropriate and includes all necessary information for the safe and effective use of the drug.
- The drug is manufactured in accordance with GMP to ensure its identity, strength, quality, and purity.
- The clinical trial data are robust and demonstrate the drug's efficacy for its intended use.
- The benefits of the drug outweigh the risks, considering the condition it is designed to treat and the patient population intended to use it.
This scrutiny extends to the evaluation of the raw data from clinical trials, not just the summaries provided by the pharmaceutical companies. FDA reviewers must be convinced that the studies were conducted ethically and that the data support the conclusions drawn.
Balancing Benefits and Risks:
One of the critical aspects of the drug approval process is the assessment of the risk-benefit balance. The CDER does not require that a drug be completely free of risk but demands a favorable risk-benefit ratio. This means that the expected therapeutic benefits must justify any potential risks associated with the drug’s use.
Ongoing Monitoring and Post-Marketing Surveillance:
The CDER's responsibility does not end with drug approval. The center engages in continual post-marketing surveillance to monitor drugs' performance in real-world settings. It oversees the implementation of Risk Evaluation and Mitigation Strategies (REMS), when necessary, to manage known or potential risks associated with a drug. Additionally, the CDER monitors adverse event reports and can require further post-marketing studies to address any emerging safety concerns.
Conclusion:
The FDA's CDER embodies the rigorous scientific and regulatory expertise required to ensure that new medicinal products entering the U.S. market are safe and effective. The meticulous approval process, along with ongoing post-market analysis, underlines a dedication to protecting American patients and reinforces the integrity of the pharmaceutical industry.
In an era where medical advancements are accelerating, Dr. Pooyan Ghamari highlights the indispensability of an agency like the CDER, which serves as the critical interface between pharmaceutical innovation and patient safety.
Its commitment to stringent regulatory scrutiny ensures that the American public can access therapeutic innovations with confidence in their safety and efficacy. The work of the CDER is thus not just regulatory in nature; it is a profound responsibility carried out with scientific rigor and a dedication to public health.
Generic top-level domain
Generic top-level domains (gTLDs) are one of the categories of top-level domains (TLDs) maintained by the Internet Assigned Numbers Authority (IANA) for use in the Domain Name System of the Internet. A top-level domain is the last label of every fully qualified domain name. They are called generic for historic reasons; initially, they were contrasted with country-specific TLDs in RFC 920.
The core group of generic top-level domains consists of the com, info, net, and org domains. In addition, the domains biz, name, and pro are also considered generic; however, these are designated as restricted, because registrations within them require proof of eligibility within the guidelines set for each.
Historically, the group of generic top-level domains included domains, created in the early development of the domain name system, that are now sponsored by designated agencies or organizations and are restricted to specific types of registrants. Thus, domains edu, gov, int, and mil are now considered sponsored top-level domains, much like the themed top-level domains (e.g., jobs). The entire group of domains that do not have a geographic or country designation (see country-code top-level domain) is still often referred to by the term generic TLDs.
This page contains text from Wikipedia, the Free Encyclopedia - https://wn.com/Generic_top-level_domain
Center for Drug Evaluation and Research (CDER) Cen...
Many just need an opportunity: Join FDA’s Center f...
Presentation 16 - The FDA and Center for Drug Eval...
Looking for the best and the brightest to join FDA...
Center for Drug Evaluation...
What can CDER do for you? (3of15) REdI Annual Conf...
How FDA is Using "Organ on a Chip" Technology to I...
Division of Applied Regulatory Science in FDA’s Ce...
How does the FDA approve new drugs? (30 seconds)...