CDR Trang Tran and CDR Elizabeth Thompson from the FDA Office of New Drugs provide an overview of the recently published draft guidance for industry titled “Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs.”
00:00 - Overview of Meeting Types and Meeting Requests
14:29 - After a Meeting Has Been Granted
31:03 - Q&A Session
FDA SPEAKERS:
Trang Tran
Commander, U.S. Public Health Service
Senior Regulatory Health Project Manager
Division of Nonprescription Drugs 1
Office of New Drugs (OND)
Office of Regulatory Operations (ORO)
Center for Drug Evaluation and Research (CDER) | FDA
Elizabeth Thompson
Commander, U.S. Public Health Service
Chief, Project Management Staff
Division of Nonprescription Drugs 2
OND | ORO
CDER | US FDA
Learn more at: www.fda.gov/dr...
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