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FDA Administrative Enforcement Manual

Sprache: Englisch.
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<P>A self-contained single source complete with pertinent references and practical outlines for policies and procedures, this book covers how to understand and comply with U.S. drug development and manufacturing regulations. It explores the con

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FDA Administrative Enforcement Manual als Buch

Produktdetails

Titel: FDA Administrative Enforcement Manual
Autor/en: Florence R. Parker

ISBN: 084933067X
EAN: 9780849330674
Sprache: Englisch.
CRC PR INC

Februar 2005 - gebunden - 480 Seiten

Beschreibung

<P>A self-contained single source complete with pertinent references and practical outlines for policies and procedures, this book covers how to understand and comply with U.S. drug development and manufacturing regulations. It explores the control of drug research and the manufacturing industry, introduces basic industry experience and techniques, and presents tried and true methods for applying the theory to everyday problems. The author discusses the 10 critical administrative enforcement areas, including recall, application integrity, injunction, seizure, and more, then supplements the topics with regulations, lawsuit case studies, enforcement information, and reference material.</P>

Inhaltsverzeichnis

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
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