Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 1, Pt 4 [Video]

The Generic Drugs Forum is an annual, two-day event with the goal of providing practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines.

Timestamps

00:06 – ANDA Program Statistics

21:33 – An Overview to the Pre-Launch Activities Importation Request (PLAIR)

29:52 – Pre-Launch Activities Importation Request (PLAIR) & The Division of Project Management (DPM)

38:11 – Information to Include with a Cover Letter

47:58 – Best Practices form Regulatory Business Process Manager (RBPM) Perspective and Communications

01:06:02 – Q&A Discussion Panel

Speakers | Panelists:

Edward (Ted) Sherwood
Director
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER) | FDA

Andrew Kim
Commander (CDR), United States Public Health Service (USPHS)
Supervisory Project Manager
Division of Project Management (DPM)
ORO | OGD | CDER | FDA

Andrei Perlloni
Branch Chief
Imports Compliance Branch (ICB)
Division of Global Drug Distribution and Policy (DGDDP)
Office of Drug Security, Integrity, and Response (ODSIR)
Offie of Compliance (OC)
CDER | FDA

Tom Ching
Regulatory Project Manager
DPM |ORO | OGD | CDER | FDA

Steven Yang
Lieutenant Commander (LCDR) | USPHS
Regulatory Business Process Manager
Division of Regulatory & Business Process Management IV (DRBPM IV)
Office of Program and Regulatory Operations (OPRO)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-gdf-2024-regulatory-considerations-enhance-generic-drug-access-04102024

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