Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 1, Pt 2

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

00:05 – Policy Accomplishments

15:33 – Policy Documents

28:34 – GDUFA III Suitability Petitions

40:14 – Recommended Supplemental In formation

49:48 – Overview of the FDA Product-Specific Guidance (PSG) Program

01:11:48 – Q&A Discussion Panel

Speakers | Panelists:

Martha Nguyen
Director
Division of Policy Development (DPD)
Office of Generic Drug Policy (OGDP)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER) | FDA

Tina Kiang, PhD
Director
Division of Regulations and Guidance (DRGS)
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA

Arlene Figueroa, JD
Regulatory Counsel
Division of Legal and Regulatory Support (DLRS)
OGDP | OGD | CDER | FDA

Rosanne Pagaduan, PharmD
Supervisory General Health Scientist
Division of Filing Review (DFR)
Office of Regulatory Operations (ORO)
OGD | CDER | FDA

Joe Kotsybar, PharmD
Regulatory Health Project Manager
Office of Research and Standards (ORS)
OGD | CDER | FDA

Reynolds (Rey) Cantave, PharmD
Senior Regulatory Health Project Manager
Enterprise Project Management Staff
Office of Quality Assurance (OQA)
OPQ | CDER | FDA

Jouhayna Saliba, PharmD
CAPT, United States Public Health Service (USPHS)
Team Leader
Drug Shortages Staff (DSS)
Office of the Center Director (OCD)
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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