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FDA administrative enforcement manual

Author: Florence R Parker
Publisher: Boca Raton, FL : Taylor & Francis, ©2005.
Edition/Format:   Print book : EnglishView all editions and formats
Database:WorldCat
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FDA Administrative Enforcement Manual

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Document Type: Book
All Authors / Contributors: Florence R Parker
ISBN: 084933067X 9780849330674
OCLC Number: 56517908
Description: xx, 456 pages : illustrations, forms ; 27 cm
Contents: Introduction DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION: AUTHORITY AND RESPONSIBILITY Statutory Authority Laws Enforced by the FDA Jurisdiction Statute of Limitations Administrative Law and Procedures Act Code of Federal Regulations Authority, Scope, and Facility Inspections Inspection Process and Procedures U.S. Constitutional Rights of Defendant Firms and Individuals Evidence, Administrative Agencies, and Federal Courts Case Studies RECALLS: CORRECTIONS AND WITHDRAWALS Statutory Authority Recall Type and Class Recall Effectiveness Monitoring Strategy Public Notification Status Reports Termination Regulated Product Withdrawals FDA Recall Facts Cases Studies CIVIL ACTIONS Seizure Injunctions CRIMINAL ACTIONS: DEBARMENT, DISQUALIFICATION, AND APPLICATION COMPLIANCE AND INTEGRITY Statutory Authority Jurisdiction Debarment Disqualifications Applications: Compliance and Validity Issues Case Studies CASE STUDIES Program Implementation FDA 483 Forms, Recalls, Corrections, and Market Withdrawals Mass Seizure Actions Injunction Actions Consent Decrees Criminal Indictments, Process, and FDA Procedures FDA Prosecution Debarment Case Study Exhibits Appendix 1.FD&C Act of 1938 Chapter III. Prohibited Acts and Penalties Seizure Chapter V. Drugs and Devices Provision of Standards General Requirement Chapter VIII. Imports and Exports Chapter IX. Miscellaneous Appendix 2: Drug Law History Synopsis Appendix 3: Clinical Investigators Clinical Investigator Regulatory Sanctions Investigator Responsibilities FDA Inspections of Clinical Investigators FDA Institutional Review Board Inspections Appendix 4: FDA Administrative Procedures Act (FAPA) Title 21 (Food and Drugs)CFR 10.1 -10.206381 Glossary Index
Other Titles: Food and Drug Administration enforcement manual
Responsibility: Florence R. Parker.
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