Fda's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions

ISBN-13: 9780128146477 / Angielski / Miękka / 2017 / 670 str.

Tom Brody

Opis

FDA's Drug Review Process and the Package Label provides a guide to pharmaceutical companies for writing FDA-submissions. This book covers all essential elements in FDA-approval including Clinical Study Reports, Investigator's Brochures, and the Common Technical Document (eCTD). Specifically, the book provides guidance to medical writers in the pharmaceutical industry for drafting FDA-submissions that will persuade FDA reviewers to grant approval to the drug. Containing excerpts copied from various package labels to demonstrate how the Sponsor's arguments, together with feedback, complaints, and suggestions from FDA reviewers, this book guides the writing of the package label, the primary component of FDA approval (rather than the drug itself). This book is essential for pharmaceutical companies, those studying or researching in drug discovery and all involved in the biotechnology industry from research to regulation.

• Demonstrates specific techniques and strategies for FDA approval
• Includes numerous real-life examples to guide writing
• Drawn from the most reliable source of information available by a veteran of the industry

Spis treści

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