Center for Drug Evaluation and Research (CDER) | FDA
As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more...
CDER Offices and Divisions | FDA
Learn more about the offices and divisions in FDA's Center for Drug Evaluation and Research (CDER)
CDER Initiatives | FDA - U.S. Food and Drug Administration
The Center for Drug Evaluation and Research (CDER) prioritizes collaborative decision-making, ensuring all scientific and regulatory expertise informs crucial drug approval choices.
Welcome to FDA Direct - direct.fda.gov
CDER Direct allows users to easily create and submit data directly to the FDA. This system will provide information to FDA/CDER about drug manufacturers and private label distributors, outsourcing facilities, wholesale drug distributors and third-party logistics, and generic drug facilities, along with their drugs in U.S. commercial distribution.
FDA Center for Drug Evaluation and Research (CDER) - NCI - Cancer
As part of the US Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The Center is a consumer watchdog in …
www.accessdata.fda.gov
The FDA's CDER database provides information on approved drugs and related resources.
FDA Creates CDER Center for Real-World Evidence Innovation
2024年12月13日 · FDA announced on Dec. 12, 2024 that the Center for Drug Evaluation and Research (CDER) has created a Center for Real-World Evidence Innovation (CCRI). The CCRI will coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) when making regulatory decisions at CDER (1).
FDA's drug center to consolidate AI efforts under single council
2024年8月29日 · The FDA’s Center for Drug Evaluation and Research (CDER) is consolidating its artificial-intelligence-related activities under a single AI Council, in part in response to efforts from the...
with FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) come in. This document is designed to help you understand when and how to ask for personalized feedback, what and how to prepare for, and what to expect during meetings with CBER and CDER.
FDA/CDER Readying Draft Guidance on AI to Support Regulatory …
2024年6月27日 · The U.S. FDA Center for Drug Evaluation and Research (CDER) is preparing to release a draft guidance later this year on artificial intelligence (AI), titled Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products, according to Tala Fakhouri, Associate Director for policy ...
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