FDA Administrative Enforcement Manual  book cover
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FDA Administrative Enforcement Manual




ISBN 9780849330674
Published February 18, 2005 by CRC Press
480 Pages 15 B/W Illustrations

 
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Book Description

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 marshals seize products if a voluntary recall is not done. Drugs can be seized and medical devices can be detained and imports can be stopped at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought.
Ensuring that your company is in compliance at all times in all departments is a never-ending task. Failure to get it right, even once, can mean excessive fines, penalties, or possible debarment. The FDA Administrative Enforcement Manual explores the control of drug research in pharmaceutical, vaccine, biologic, biotechnology, medical device, and cosmeceutical industries. Introducing basic industry techniques, the author explores every day industry problems and presents suggested methods for applying the theory to resolve them.

The book covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more. It supplements these topics with regulations, lawsuit case studies, enforcement information, and reference materials. Offering insight into the impact of FDA enforcement on the national and international pharmaceutical industry, practitioners and industry suppliers, the book provides an understanding of drug development and manufacturing regulations in the United States and shows you what it takes to keep your company in compliance. The only complete, single source available, the FDA Administrative Enforcement Manual draws on the author's experience in the trenches of the pharmaceutical industry with administrative enforcement activities.

Table of 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

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Reviews

"The only complete, single source available…the book provides an understanding of drug development and manufacturing regulations in the United States and how a company may comply with them."
--Anticancer Research