GDF 2024 | D2S02 - GDSA-BE: Modernizing Bioequivalence Assessment for Abbreviated New Drug...

Описание: This presentation explored the Generic Drug Science and Accessibility-Bioequivalence (GDSA-BE) initiative and its role in modernizing bioequivalence assessment for Abbreviated New Drug Applications. The session outlined how this program advances scientific approaches and improves accessibility in generic drug development through updated bioequivalence evaluation methods.

Timestamps

02:25 – Need for Modernization -Technology Advancement

05:44 – OGD Strategic Priorities (2023 – 2028)

07:00 – OGD Generic Drug Structured Assessment (GDSA)

15:11 – Summary

Speaker:

Tao Bai, PhD
Senior Advisor
Office of Bioequivalence Immediate Office (OBIO)
Office of Generic Drugs (OGD)
Center for drug Evaluation and Research (CDER) | FDA

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

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