Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 3 [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

00:08 – ANDA Submissions: Risk-Based Extractable and Leachable Quality Information

12:32 – Extractables and Leachables from CCS

23:33 – Facility Assessment for Pre-Marketing Applications: Inspections and Remote Regulatory Assessments

33:41 – GDUFA III Implementation – Facility Related Updates

50:15 – Emerging Technology Program (ETP) and Advanced Manufacturing Technologies Designation Program (AMTDP): Which Advanced Manufacturing Program is Right for Me?

01:03:12 – Q&A Discussion Panel

Speakers | Panelists:

Kshitij Patkar, PhD
Senior Pharmaceutical Quality Assessor
Division of Pharmaceutical Manufacturing Assessment I (DPMA I)
Office of Pharmaceutical Manufacturing Assessment (OPMA)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA

Jin Xu, PhD
Senior Pharmaceutical Quality Assessor
Division of Product Quality Assessment IX (DPQA IX)
Office of Product Quality Assessment II (OPQA II)
OPQ | CDER | FDA

Derek Smith, PhD
Deputy Director
Office of Pharmaceutical Manufacturing Assessment (OPMA)
OPQ | CDER | FDA

Rakhi Shah, PhD
Associate Director
OPMA | OPQ | CDER | FDA

Elisa Nickum, PhD, PMP
Senior Regulatory Health Project Manager
Office of Program and Regulatory Operations (OPRO)
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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