CMC Considerations for Biotechnology Product Development: A Regulatory Perspective

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: www.fda.gov/dr...
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