Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 2

Описание: Kevin Bugin, Deputy Director for Operations for the Office of New Drugs (OND) provides a background and overview of the prescription drug user fee act (PDUFA) and discusses themes of the
upcoming PDUFA VII proposed enhancements and the process for reauthorization. Jeannie Roule, Chief Project Management Staff within the Division of Regulatory Operations for Rare Diseases,
Pediatrics, Urologic and Reproductive focuses on types of meetings between a Sponsor or Applicant and the FDA and share best practices for meeting interactions with OND.


00:00 – PDUFA Program Overview and Reauthorization Process Update
16:15 – Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants
of PDUFA Products 45:00 – Question and Answer Panel


SPEAKERS:

Kevin Bugin, PhD, MS, RAC
Deputy Director for Operations
Office of New Drugs (OND) | CDER

Jeannie Roule
Chief, Project Management Staff
Urology, Obstetrics, and Gynecology
Division of Regulatory Operations for Rare Diseases,
Pediatrics, Urologic and Reproductive (DRORDPURM)
Office of Regulatory Operations (ORO)
OND | CDER


Learn more at: https://www.fda.gov/drugs/news-events...

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