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CMC Considerations for Biotechnology Product Development: A Regulatory Perspective 

U.S. Food and Drug Administration
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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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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
Upcoming Training - www.fda.gov/cd...
SBIA Listserv - public.govdeli...
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SBIA LinkedIn - / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cd...
Twitter - / fda_drug_info  
Email - CDERSBIA@fda.hhs.gov  
Phone - (301) 796-6707 I (866) 405-5367

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9 июл 2024

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