Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products.
This report offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products.
Chapter 2 Preclinical Safety Assessments
Chapter 3 The Biological IND
Chapter 4 The Biological IND Review Process in CBER and CDER
Chapter 5 Clinical Testing of Biologically Derived Therapeutics
Chapter 6 The Clinical Evaluation of Preventive Vaccines for Infectious Disease Indications
Chapter 7 Good Clinical Practices
Chapter 8 The Biologics License Application (BLA)
Chapter 9 Manufacturing Arrangements for Biological Products
Chapter 10 The Biological License Application (BLA) Review Process
Chapter 11 Post-Licensure Requirements
Chapter 12 Bioresearch Monitoring Program for Biologics
Chapter 13 Biologics and the Regulation of Combination Products