Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.

Guidebook for Drug Regulatory Submissions includes:

• Meeting Requests
• Orphan Drug Applications
• Investigatory New Drug Applications (INDAs)
• New Drug Applications (NDAs)
• 505(b)2 NDAs
• Abbreviated New Drug Applications (ANDAs)
• Annual Report

Contents

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

Index

click here to see books of related interest