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                Guidance, Compliance, & Regulatory Information

Guidance, Compliance, & Regulatory Information

                        Good Review Practices | GRPs


                        Guidances | Drugs
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          Drugs
          Guidance, Compliance, & Regulatory Information
          Drug Compliance ProgramsGuidance, Compliance, & Regulatory Information Drug Compliance Programs
  
  	
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    PrintFDA 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 Title7348.001
			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 Inspections7356.000
			Inspections of CDER-led or CDRH-led Combination Products (PDF - 811 KB)7356.002
			Drug Manufacturing Inspections (PDF - 524 KB)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 Drugs7356.013
			Import Human Drug Operations
			(Not available online)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)7356.843
			Postapproval Inspections (PDF - 592KB)7361.003
			OTC Drug Monograph Implementation (PDF - 51KB)7363.001
			Fraudulent Drugs (PDF - 68KB)

Resources For You

Office of Compliance
	Chapter 4 - Human Drugs
	Clinical Investigator Inspection List (CIIL) Database Codes

                                                                                  Content current as of:
      09/20/2023
              
              
Regulated Product(s)
		 DrugsGuidance, Compliance, & Regulatory Information

          
                        Good Review Practices | GRPs


                        Guidances | Drugs
          Electronic Drug Registration and Listing System (eDRLS)
          CDER FOIA Electronic Reading Room
          CDER International Program
          Enforcement Activities | FDA
          Human Drug Compounding
          Human Drug Exports
          Human Drug Imports
          Laws, Acts, and Rules
          Postmarketing Requirements and Commitments: Introduction
          Surveillance: Post Drug-Approval Activities
 
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