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June 5, 2024

CDER Exclusivity Board

CDER has established an Exclusivity Board to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency […]
June 5, 2024

Division of Applied Regulatory Science

What We Do The Division of Applied Regulatory Science (DARS) moves new science into the FDA regulatory process and addresses emergent regulatory and public health questions. […]
June 4, 2024

Meeting Presentations | Drugs

CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users […]
June 4, 2024

FDA Roundup: June 4, 2024

For Immediate Release: June 04, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]
June 4, 2024

Drug Info Rounds Video: Expanded Access

CAPT Kremzner: Expanded access allows patients to use investigational drugs outside of clinical trials. Hi, I’m Captain Mary Kremzner, and this is Drug Info Rounds, brought to […]
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