1-4 - CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

1-4-1 - Office Of Compliance (HFD-300)

The Office of Compliance ensures that safe and effective drugs are available to the American people.

The Division of Scientific Investigation was transferred to the office in May, 2006.

The functional statements for the Office of Compliance are:  

1. Protects the American public from unsafe and ineffective drugs by addressing public health risks associated with legal violations;
2. Develops and oversees drug compliance programs designed to reduce consumer exposure to risks of unsafe and ineffective drugs;
3. Monitors the quality of human drugs through inspectional coverage, product testing, and other pre- and post-market surveillance activities;
4. Advises the center director and other agency officials on regulatory and enforcement issues involving human drugs;
5. Coordinates center-field relations and provides support and guidance to field offices on case development and regulatory actions; ensures uniform interpretation of standards;
6. Develops policies and compliance strategies to ensure that OTC and Rx drugs are of high quality, properly labeled, safe, pure, and meet applicable drug approval requirements;
7. Develops policy and standards to achieve high product quality through application of current good manufacturing practice requirements; coordinates surveillance and pre-approval inspections;
8. Coordinates evaluation and classification of drug recalls and provides center coordination with field offices for implementation of recalls; monitors resolution of drug shortage situations involving compliance issues; and, 
9. Implements programs and projects to identify, assess, and prioritize the public health significance of legal violations and develops and utilizes innovative enforcement strategies to reduce public health risks associated with legal violations. 

There are four divisions within the Office of Compliance:

1. Division of New Drugs and Labeling Compliance;
2. Division of Manufacturing and Product Quality;
3. Division of Compliance Risk Management and Surveillance; and,
4. Division of Scientific Investigation.

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1-4-2 - Division Of New Drugs And Labeling Compliance (HFD-310)

The division’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 drugs, prescription (Rx) drugs, and drugs falling within the health fraud program area.

The division consists of five teams, the OTC Drugs Team, the Internet and Health Fraud Team, the Compounding Team, the New Drugs and Labeling Team, and the Import-Export Team.  The functional statements for the Division of New Drugs and Labeling Compliance are:

1. Protects the public health by assuring 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; 
2. Develops compliance strategies, programs and policy guides to ensure that all OTC and Rx drugs marketed in the United States are properly labeled and meet applicable new drug requirements and to remove from the market fraudulent drug products that pose direct or indirect public health risks;
3. Maintains the integrity of imported drug products by assuring their compliance with applicable legal requirements;
4. Provides guidance and consults on export policies and procedures;
5. Directs field inspections and investigations and recommends, directs and/or coordinates case development and compliance actions regarding OTC, Rx, and health fraud drug products;
6. Provides enforcement and litigation support and guidance for OTC, Rx, and health fraud drugs, including support for State Attorney General and Office of Criminal Investigation cases;
7. Provides guidance and interpretation of drug establishment registration and drug product listing regulations involving domestic and imported drug products;
8. Develops legislative proposals, implementing regulations, policy and guidance documents, enforcement strategies, and outreach activities relating to pharmacy compounding;
9. Monitors the Internet in support of division enforcement initiatives, actions and outreach programs; and,
10. Prioritizes unapproved drugs identified for regulatory action using risk based assessment and develops compliance strategies to address the most significant legal violations.

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1-4-3 - Division Of Manufacturing And Product Quality (HFD-320)

The division 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 division consists of the Case Management and Guidance Branch, the Investigations and Preapproval Compliance Branch, and the Therapeutics Facilities Review Branch. The CDER recall program also operates from this division. The program is part of the immediate office of the division director.

The functional statements for the Division of Manufacturing and Product Quality are:

1. Serves as agency focal point regarding compliance of establishments and products with current good manufacturing practices (CGMP) and other adulteration provisions of the Federal Food, Drug and Cosmetic Act; 
2. Ensures the quality and purity of marketed human drug products through enforcement of the CGMP regulations for the manufacture, testing and holding of human drugs; develops and directs the CDER drug product quality enforcement programs;
3. Provides clear and consistent guidance to FDA field personnel, industry and foreign governments on manufacturing quality requirements for human drug products;
4. Ensures rapid access to quality new human drugs by verifying new drug application commitments, CGMP compliance, and supporting data before and after application approval; develops and implements strategies for alleviation of drug shortages/drug supply problems;
5. Ensures that the appropriate corrective action is taken when human drug products are unsafe or adulterated; manages the CDER product recall program and coordinates Office of Compliance emergency operations;
6. Develops guidance materials and educational programs to promote compliance with drug good manufacturing practice requirements;
7. Develops agency compliance policy for enforcement of the Federal Food, Drug, and Cosmetic Act regarding drug product quality;
8. Processes regulatory actions involving drug product quality requirements and supports litigation arising from regulatory actions;
9. Promotes goodwill and cooperation between the United States and foreign governments through the Export Certificate Program, which enables American manufacturers to export their products to foreign customers and governments and demonstrates that drugs for export meet applicable legal standards; 
10. Proposes and implements agreements with foreign governments for harmonization of requirements and program efficiencies for assuring human drug product quality;
11. Reviews chemistry manufacturing controls (CMC) submission for the approval of biological license applications (BLA) and supplements, focusing on areas relevant to manufacturing controls, microbiology product quality, and sterility assurance of
    biotech drugs;
12. Serves as the lead investigator for preapproval inspections for BLA and BLA supplements; and,
13. Serves as the technical experts in biotech drug manufacturing and controls.

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1-4-4 - Division Of Compliance Risk Management And Surveillance (HFD-330)

The division’s primary responsibility is to advance the office mission through implementation of programs and projects that identify, assess and prioritize legal violations based upon their public health significance.  This approach requires qualitative and quantitative data analyses and the use of strategic problem solving to target compliance actions and develop innovative enforcement strategies for reducing public health risks associated with violative drug products.

The division is composed of the Surveillance and Data Analysis Branch which includes the Risk Management and Strategic Problem Solving Team, Surveillance Programs Team, Data Analysis and Information Management Team, and Drug Registration and Listing Team.   The functional statements for the Division of Compliance Risk Management and Surveillance are:

1. Fosters the use of risk-based approaches to compliance and enforcement actions undertaken by the office;
2. Applies qualitative and quantitative analysis to identify, assess and prioritize legal violations for compliance action based upon their public health significance;
3. Utilizes strategic problem solving to select projects for intervention and to develop and evaluate the effectiveness of such interventions in reducing the public health risks associated with violative drug products; 
4. Works closely with other agency units in areas of strategic planning, identification of priorities, and development of risk-based compliance initiatives;
5. Monitors the quality of the nation's drug supply through post-market surveillance activities, including overseeing the sampling and analysis of drugs and directing compliance activities pertaining to the postmarketing adverse drug experience reporting requirements; and, 
6. Develops expertise in working with office and agency databases, including drug surveys, Drug Quality Reporting and NDA Field Alert System, AERS, Drug Recalls and Shortages, Establishment Evaluation System, Drug Registration and Listing System, Prescription Drug Marketing Act, DESI Federal Register database, Turbo EIR and FACTS; and also establishes familiarity with relevant databases outside the office and agency.

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1-4-5 - Division of Scientific Investigations (HFD-45)

The division’s primary responsibility is to verify the integrity of efficacy and safety data submitted to the FDA in support of new drug applications and to assure that the rights and welfare of human research subjects are protected.

The division is composed of two clinical review branches (Good Clinical Practices Branch I and Good Clinical Practices Branch II) and the Good Laboratory Practices/Bioequivalence Branch.

The functional statements for the Division of Scientific Investigations are:

1. 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, and other Federal statutes, and applicable regulations.
2. Develops standards for the conduct of clinical and nonclinical investigations performed to demonstrate the safety and effectiveness of drug and biologic
   products.
3. Designs and operates surveillance and compliance programs in the areas of nonclinical and clinical drug products investigations, bioequivalence studies, and human subject protections. Assigns, directs and coordinates onsite inspections of sponsors and investigators of preclinical and clinical drug product studies, bioequivalence, biopharmacokinetics, and biopharmacodynamic studies and the laboratories used for these studies, institutional review committees, and commercial clinical testing facilities in collaboration with the Agency's field organization. Evaluates investigation reports, develops and issues correspondence to the inspected party, and initiates administrative and regulatory corrective measures as necessary.
4. Evaluates complaints related to the nonclinical and clinical drug investigations, initiates appropriate follow-up strategy including inspections, and, as necessary, generates regulatory or administrative actions.

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