FDA Administrative Enforcement Manual: 1st Edition (e-Book) book cover

FDA Administrative Enforcement Manual

1st Edition

By Florence R. Parker

CRC Press

480 pages

Purchasing Options:$ = USD
Hardback: 9780849330674
pub: 2005-02-18
eBook (VitalSource) : 9780429125065
pub: 2005-02-18
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When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshal

Table of Contents

Department of Health and Human Services, U.S. Food and Drug Administration: Authority and Responsibility. Recalls: Corrections and Withdrawals. Civil Actions. Criminal Actions: Debarment, Disqualification, and Application Compliance and Integrity. 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.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology