Biologics Development: A Regulatory Overview (2021)

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Originally written by CDER and CBER officials and industry experts, the newly-updated Biologics Development: A Regulatory Overview offers an extensive examination of the FDA’s regulations and guidelines for biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. The book also provides a detailed look inside the approval pathway for today’s biological products along with an analysis of each stage of the biological product development process, including:

• CDER organization and processes for regulating and reviewing therapeutic biological products.
• CDER’s processes for regulating and reviewing cellular/tissue-based products and gene therapies, vaccines, and blood products.
• How CDER and CBER have evolved their procedures and requirements to address new challenges including risk management priorities and internal agency initiatives.
• Applications of updated ICH GCP E6 and E8 guidelines to biological products development.
• Emerging standards for the clinical and nonclinical testing of biological products, including combination products and biosimilars.

“Authored by FDA and industry officials, Biologics Development: A Regulatory Overview is the first text to provide a detailed analysis of the FDA’s regulation of the development process for… biological products. [It] gives special emphasis to the recent wave of organizational, management, and operating initiatives within… CBER… including lot release, user fees, and promotional labeling policies.” 
RAPS News 

“A first-rate information source on the biologics approval process! This text provides an up-to-date reference for the expert, and an excellent overview for the novice. More important, it is one of the precious few sources for obtaining the detailed thoughts of current CBER officials.”
Gary E. Gamerman, M.S., J.D., Fenwick & West