Biotechnology and Biologic Products Regulation (Food and Drug Law Book 6)

This volume focuses on important issues concerning biologics. Each chapter contains critical analysis issues to explore. This volume includes a strategic goal plan for the Center for Biologics Evaluation and Research (CBER). The authority of CBER stems from the Public Health Services Act (PHSA) and specific sections of the United States Food Drug and Cosmetic Act (FDCA). Both the PHSA and FDCA impact on these regulated products. Critical parameters in the regulation of these products remains science based to assure purity, potency, safety, efficacy, and availability. Special topics cover biosimilars, bioterrorism and botulinum Toxin Type A “Botox”. Examples of voluntary recalls, gene therapy initiatives, warning letters are included. Critical analysis issues are in each chapter.