FDA administrative enforcement manual [electronic resource] / Florence R. Parker.
This manual is a self-contained single source complete with pertinent references and practical outlines for policies and procedures to understand and comply with US drug development and manufacturing regulations.
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Full Text (via Taylor & Francis) |
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Main Author: | |
Other title: | Food and Drug Administration enforcement manual. |
Format: | Electronic eBook |
Language: | English |
Published: |
Boca Raton, FL :
Taylor & Francis,
©2005.
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Subjects: |
Table of Contents:
- Front Cover; Preface; The Author; Acknowledgments; Contents; Introduction; Chapter 1: Department of Health and Human Services, U.S. Food and Drug Administration: Authority and Responsibility; Chapter 2: Recalls: Corrections and Withdrawals; Chapter 3: Civil Actions; Chapter 4: Criminal Actions: Debarment, Disqualification, and Application Compliance and Integrity; Chapter 5: Case Studies; Appendix 1: FD & C Act of 1938; Appendix 2: Drug Law History Synopsis; Appendix 3: Clinical Investigators; Appendix 4: FDA Administrative Procedures Act (FAPA); Glossary; Index.