Guidebook for Drug Regulatory Submissions
Material type:
TextPublication details: New Jersey John and Wiley Sons, Inc. 2009Description: 379pISBN: - 9780470371381
- 344.7304233 WEI
| Item type | Current library | Item location | Collection | Call number | Status | Date due | Barcode | Item holds | |
|---|---|---|---|---|---|---|---|---|---|
Reference Book
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NIMA Knowledge Centre | 7th Floor Silence Zone | Reference | 344.7304233 WEI (Browse shelf(Opens below)) | Not For Loan | P0006995 |
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| 344.7304232 FOR Food Regulation: Law, Science, Policy and Practice | 344.7304232 FOR Food Regulation: Law, Science, Policy and Practice | 344.7304233 MER Pharmacy Law and Practice | 344.7304233 WEI Guidebook for Drug Regulatory Submissions | 346.0486 MAT Fundamentals of Patenting and Licensing for Scientists and Engineers | 346.730486 BOU Patently Innovative : how pharmaceutical firms use emerging patent law to extend monopolies on blockbuster drugs | 361.763 WOR The World Health Report 2003: Shaping the Future |
Destined to become every regulatory director's essential desktop companion.rofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. 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.Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.
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