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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Bibliographic Details
Online Access: Full Text (via Taylor & Francis)
Main Author: Parker, Florence R.
Other title:Food and Drug Administration enforcement manual.
Format: Electronic eBook
Published: Boca Raton, FL : Taylor & Francis, ©2005.
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.