Inspections, Compliance, Enforcement, and Criminal Investigations
1-4 - CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
1-4 - CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
1-4-1 - Office of Compliance
1-4-2 - Office of Unapproved Drugs and Labeling Compliance
1-4-3 - Office of Manufacturing and Product Quality
1-4-4 - Office of Drug Security, Integrity and Recalls
1-4-5 - Office of Scientific Investigations
The Office of Compliance ensures that safe and effective drugs are available to the American people.
The functional statements for the Office of Compliance are:
- Promotes and protects the public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs;
- Proactively advises the Center Director and other Agency officials on FDA’s regulatory and enforcement responsibilities and possible risks associated with human drugs, application integrity, and human subject protection;
- Strategically implements programs and projects to identify, assess, and prioritize the public health significance of legal violations presented throughout the drug lifecycle;
- Develops and utilizes innovative enforcement strategies and risk-based decision making to reduce public health risk by ensuring that marketed drugs are of high quality and integrity, properly labeled, safe, pure, and meet applicable drug approval requirements; and,
- Coordinates Center-field relations and provides support and guidance to field offices on case development and regulatory actions, and ensures uniform interpretation of standards.
As a result of reorganization efforts in 2011, the following four Offices were created within the Office of Compliance:
- Office of Unapproved Drugs and Labeling Compliance;
- Office of Manufacturing and Product Quality;
- Office of Drug Security, Integrity and Recalls; and,
- Office of Scientific Investigation
The Office’s primary responsibility is to protect the public health by ensuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act as it relates to over-the-counter (OTC) drugs, prescription (Rx) drugs, and drugs falling within the health fraud program area.
The Office consists of two Divisions, the Division of Prescription Drugs and the Division of Non-Prescription Drugs and Health Fraud. The functional statements for the Office of Unapproved Drugs and Labeling Compliance are:
- Develops policies and compliance strategies for protecting the public health by assuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act, and
- Uses risk based assessments and strategic enforcement actions to identify and address products that pose the most significant risks to consumers associated with unapproved and misbranded drugs.
The Office is the agency focal point for comprehensive regulatory oversight of the human drug manufacturing industry to ensure that drug products offered in the U.S. marketplace are not adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act.
The Office consists of the Division of Domestic Drug Quality, the Division of Good Manufacturing Practice Assessment, the Division of International Drug Quality, and the Division of Policy, Collaboration and Data Operations. The functional statements for the Office of Manufacturing and Product Quality are:
- Develops policies, surveillance activities, and compliance strategies to protect public health by assuring compliance with Current Good Manufacturing Practices (CGMP) requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act);
- Uses risk-based assessments and strategic enforcement actions to identify and address the most significant legal violations associated with drug manufacturing or product quality;
- Reviews field recommendations and findings, and initiates appropriate regulatory actions against violative manufacturers;
- Develops, contributes and formalizes regulatory strategies, guidance, and policies including preparing regulations, industry guidance, Compliance Program Guidance Manuals, Compliance Policy Guides, CDER MaPPs, and Staff Guidance Manuals to promote compliance with CGMP, and
- Provides technical and scientific assistance in the area of manufacturing and product quality.
The Office’s primary responsibility is to promote and protect the integrity of the global supply chain throughout the drug lifecycle to minimize consumer exposure to unsafe, ineffective, and poor quality drugs.
The Office consists of the Division of Supply Chain Integrity and the Division of Import Operations and Recalls. The functional statements for the Office of Drug Security, Integrity and Recalls are:
- Develops policies and compliance strategies for protecting the public health by assuring drug product integrity and supply chain security;
- Coordinates evaluation and classification of drug recalls and provides Center coordination with field offices for implementation of recalls and monitors resolution of related compliance issues; and
- Ensures integrity of imported drug products by assuring compliance with applicable legal requirements.
The Office’s primary responsibilities include verifying the integrity of efficacy and safety data submitted to the FDA in support of new drug applications, assuring that the rights and welfare of human research subjects are protected, assuring that responsible parties submit required postmarking adverse events and reports, and assuring sponsor compliance with the Risk Evaluation and Mitigation Strategies (REMS) requirements.
OSI is composed of three Divisions (Division of Good Clinical Practices Compliance; Division of Safety Compliance; and Division of Bioequivalence and Good Laboratory Practice Compliance).
The functional statements for the Office of Scientific Investigations are:
- Develops policies, surveillance activities, and compliance strategies relating to nonclinical and clinical drug product studies, bioequivalence studies, human subject protections, post-market Adverse Drug Experience reporting requirements, Risk Evaluation and Mitigation Strategies, and commitments for Postmarketing Requirements and Safety Labeling;
- Develops and implements the Agency's Bioresearch Monitoring Program for Human Drugs under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, the Food and Drug Amendments Act, other Federal statutes, and applicable regulations; and
- Develops, contributes and formalizes regulatory strategies and guidance including CDER MaPPs, Staff Guidance Manuals, and Compliance Program Guidance Manuals to promote compliance with Good Clinical Practice (GCP) in research, human subject protections, Good Laboratory Practices, Bioequivalence, Pharmacovigilance, Risk Evaluation and Mitigation Strategies, and Safety Labeling.