Guidebook for Drug Regulatory Submissions

SANDY WEINBERG is the former Vice President for Regulatory Affairs and Quality Assurance at Tikvah Therapeutics, Inc., and is now Associate Professor of Health Care Management and Director of the Master in Health Administration Graduate Program at Clayton State University in Atlanta. He has thirty years of experience in the field of drug regulatory affairs and is the author of twelve books, most recently Good Laboratory Practice Regulations, Fourth Edition.

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.