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Navigating the Pre-Approval and Approval Process for Drugs and Biologics - Banner Witcoff

Summary by Banner Witcoff

Banner Witcoff’s Mercedes Meyer, Ph.D., will present at the American Conference Institute’s (ACI)FDA Bootcamp on Wednesday, March 19. Mercedes and her co-presenter will discuss the pre-approval and approval process for drugs and biologics. The presentation will cover: The Drug Review Process Reviewing the fundamentals of applications; from submission, through filing and beyondMaking sense of PDUFA Goals, fast track, break through status, and oth…

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Navigating the Pre-Approval and Approval Process for Drugs and Biologics - Banner Witcoff

Banner Witcoff’s Mercedes Meyer, Ph.D., will present at the American Conference Institute’s (ACI)FDA Bootcamp on Wednesday, March 19. Mercedes and her co-presenter will discuss the pre-approval and approval process for drugs and biologics. The presentation will cover: The Drug Review Process Reviewing the fundamentals of applications; from submission, through filing and beyondMaking sense of PDUFA Goals, fast track, break through status, and oth…

25 days ago

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Banner Witcoff broke the news in 25 days ago on Monday, March 17, 2025.

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