FDA Administrative Enforcement Manual: 1st Edition (Hardback) book cover

FDA Administrative Enforcement Manual

1st Edition

By Florence R. Parker

CRC Press

480 pages | 15 B/W Illus.

Purchasing Options:$ = USD
Hardback: 9780849330674
pub: 2005-02-18
$175.00
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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.

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

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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology