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 – Pediatric Excipient Evaluation: BE Perspective
23:02 – GDSA-BE: Modernizing Bioequivalence Assessment for Abbreviated New Drug Applications
39:40 – Bio-IND Best Practices: An Analysis of Common Clinical Safety Hold and Non-hold Issues
55:20 – Comparative Analyses Update
01:07:40 – Successful Practices for Pharmacology/Toxicology Justification in ANDAs
01:26:54 – Q&A Discussion Panel
Speakers | Panelists:
Yang Lu, PhD
Senior Staff Fellow
Division of Bioequivalence III (DB III)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for drug Evaluation and Research (CDER) | FDA
Tao Bai, PhD
Senior Advisor
Office of Bioequivalence Immediate Office (OBIO)
Office of Generic Drugs (OGD)
CDER | FDA
Andrea Dugas, MD, PhD
Physician
Division of Clinical Safety and Surveillance (DCSS)
Office of Safety and Clinical Evaluation (OSCE)
OGD | CDER | FDA
Shabnam Foroughi, MD
Physician
Division of Clinical Review (DCR)
OSCE | OGD | CDER | FDA
Jimena Dancy, PhD
Pharmacologist
Division of Pharmacology/Toxicology Review (DPTR)
OSCE | OGD | CDER | FDA
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