Guidebook for drug regulatory submissions [electronic resource] / Sandy Weinberg.
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 t...
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Full Text (via Wiley) |
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| Main Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J. :
John Wiley,
©2009.
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| Subjects: |
Table of Contents:
- Ten rules for drug regulatory submissions
- FDA meeting requests
- Orphan-drug applications
- Investigational new drug applications (INDs)
- New drug applications (NDAs)
- 505(b)2 new drug applications (NDAs)
- Abbreviated new drug applications (ANDAs)
- Annual reports
- International submissions / Carl A. Rockburne
- Future issues in regulatory submissions.