CMC Considerations for Biotechnology Product Development: A Regulatory Perspective

Автор: U.S. Food and Drug Administration

Загружено: 2024-07-10

Просмотров: 6456

Описание: FDA discusses regulatory expectations for biotechnology products, regulatory challenges, and strategies for success.
Presenters:
Wendy Weinberg, PhD, Chief, Laboratory of Molecular Oncology
Kristen Nickens, PhD, Product Quality Team Lead
Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality (OPQ), CDER

Learn more at: https://www.fda.gov/drugs/news-events...
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CMC Considerations for Biotechnology Product Development: A Regulatory Perspective

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