Main description:

The high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the inexperienced regulatory professional charged with preparing a major regulatory submission. This book provides regulatory professionals with the key tools necessary to submit major documents to the United States Food and Drug Administration. The book consists of thirteen chapters, including an introductory and conclusion chapter and 11 units, each consisting of an introductory essay, submission checklist, evaluation checklist giving guidance on FDA criteria, and copies of relevant FDA documents.

Contents:

Chapter 1. Ten Rules for Drug Regulatory Submissions. Chapter 2. FDA Meeting Requests. Chapter 3. Orphan Drug Applications. Chapter 4. Investigatory New Drug Applications (INDs). Chapter 5. New Drug Applications (NDAs). Chapter 6. 505(b)2 New Drug Applications. Chapter 7. Abbreviated New Drug Applications (ANDAs). Chapter 8. Annual Reports. Chapter 9. International Submissions (Carl A. Rockburne). Chapter 10. Future Issues in Regulatory Submissions.