FDA Administrative Enforcement Manual covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more.

Features:

• Discusses the FDA Administrative Enforcement's authority, detailing what they can and cannot do
• Explores the options firms have when faced with FDA Administrative Enforcement actions
• Includes case studies to illustrate the 10 FDA enforcement areas and actions
• Contains examples of real enforcement letters, injunctions, consent decrees, and other examples of FDA enforcement activities
• Delineates practical, hands-on methods to resolve diversified pharmaceutical problems
• Presents single-source coverage of all regulated areas cGMP, GCP, GLP, advertising and promotional literature and FDA Administrative Enforcement avenues

Contents

Department of Health and Human Services, U.S. Food and Drug Administation: Authority and Resposibility

• 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

Index

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