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  1. Guidance, Compliance, & Regulatory Information

Drug Compliance Programs

FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind FDA or the public. Alternative approaches may be used as long as said approaches satisfy the requirements of applicable statutes and regulations. These programs are intended for FDA personnel but are made available electronically to the public as they become available.

The FDA Compliance Program Manual listing is available at Compliance Program Manual

Program No. Compliance Program Title
7348.001 In Vivo Bioequivalence (PDF - 77KB)
[HTML version]
7348.809A Radioactive Drug Research Committee (PDF - 142KB)
7346.832 Preapproval Inspections (PDF - 700KB)
7352.002 Unapproved New Drugs (Marketed, Human, Prescription Drugs only) (PDF - 52KB)
[HTML version]
7352.004 In Vitro Methods Development and Validation for Generic Drugs
(Not available online)
7353.001 Postmarketing Adverse Drug Experience (PADE) Reporting Inspections

Inspections of CDER-led or CDRH-led Combination Products (PDF - 811 KB)

7356.002 Drug Manufacturing Inspections (PDF - 535KB) 
7356.002A Sterile Drug Process Inspections (PDF - 292KB)
7356.002B Drug Repackers and Relabelers (PDF - 182KB)
7356.002C Radioactive Drugs (PDF - 180KB)
7356.002E Compressed Medical Gases (PDF - 239KB)
7356.002F Active Pharmaceutical Ingredients (PDF - 150 KB)
7356.002M Surveillance Inspections of Protein Drug Substance Manufacturers (PDF - 940KB)
7356.002P Positron Emission Tomography (PDF - 183KB)
7356.008 Drug Quality Sampling and Testing - Human Drugs
7356.014 Drug Listing
(Not available online)
7356.014A Drug Listing - Labeling Review
(Not available online)
7356.020 Compendial Monographs Evaluation and Development (CMED)
(Not available online)
7356.020A Compendial Methods Assessment
(Not available online)
7356.021 Drug Quality Reporting System (DQRS) (MedWatch Reports) NDA Field Alert Reporting (FARs)
7356.022 Enforcement of the Drug Sample Distribution Requirements of the Prescription Drug Marketing Act (PDMA)
7361.003 OTC Drug Monograph Implementation (PDF - 51KB)
7363.001 Fraudulent Drugs (PDF - 68KB)

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