FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label.
By:
Tom Brody (Contract Researcher Baker Hostetler San Francisco CA USA)
Imprint: Academic Press Inc
Country of Publication: United States
Dimensions:
Height: 235mm,
Width: 191mm,
ISBN: 9780128146477
ISBN 10: 0128146478
Pages: 656
Publication Date: 01 December 2017
Audience:
Professional and scholarly
,
Undergraduate
Format: Paperback
Publisher's Status: Active
1. Introduction2. FDA's decision-making process when assessing ambiguous data3. Food effect studies4. Dose modification and dose titration5. Contraindications6. Animal studies7. Drug-drug interactions -- Part One (small molecule drugs)8. Drug-drug interactions -- Part Two (therapeutic proteins)9. Immunosuppression, drug-induced hypersensitivity reactions, and drug-induced autoimmune reactions10. Drug class analysis11. Relatedness12. Adjudication of clinical data13. Coding14. Pooling
