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    PrintThe table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.

If you cannot find the document you’re looking for here, you can browse separate collections of guidance documents by topic.

Go to Guidance Document Search

Browse Guidance Documents By Topic
	COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
	General and Cross-Cutting Topics
	Advisory Committees
	Animal and Veterinary
	Biologics
	Clinical Trials
	Color Additives
	Combination Products
	Cosmetics
	Drugs
	Product-Specific Guidances for Generic Drug Development (Bioequivalence Recommendations)
	Food
	Import and Export
	International Council for Harmonisation (ICH) - select "ICH" in the Topic filter of the Guidance Document Search
	Medical Devices
	Radiation-Emitting Products
	Tobacco Products
	Veterinary International Conference on Harmonization (VICH)

About FDA Guidance Documents
	Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

If you believe an FDA employee is not following FDA's Good Guidance Practice regulations (21 CFR 10.115), you should contact the employee's supervisor in the issuing office or Center.  If the issue is not resolved, contact the next highest supervisor or the Center's Ombudsman.  If the issue is still not resolved, contact the FDA's Office of the Ombudsman at:

FDA Office of the Ombudsman
10903 New Hampshire Avenue
WO Bldg. 1, room 4208
Silver Spring, MD 20993
Phone : 301-796-8530
Email:  Ombuds@oc.fda.gov

Some Web links (URLs) embedded within guidance documents may have changed since the document was published. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.

Commenting on Guidance Documents
	Some FDA guidance documents on this list are indicated as open for comment. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on a draft guidance that is open for comments before it begins work on the final version of the guidance, submit either electronic or written comments by the closing date. Comments are submitted electronically through regulations.gov. For more information, see:

How to Use Regulations.gov
	Find and Comment on FDA Dockets

Report on Good Guidance Practices
	As part of the FDA's Transparency Initiative, Dr. Margaret A. Hamburg, the Commissioner of Food and Drugs, called for a cross-Agency working group to prepare a report identifying FDA's "best practices" for making the agency’s guidance development processes more transparent and efficient.

The working group prepared a report, entitled "Food and Drug Administration Report on Good Guidance Practices:  Improving Efficiency and Transparency."

Fact Sheet: FDA Good Guidance Practices
	Report on Good Guidance Practices:  Improving Efficiency and Transparency
	Federal Register Notice of Availability

Go to Class II Special Controls Documents

Guidance Document Search
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      Product
              Animal & VeterinaryBiologicsCosmeticsDietary SupplementsDrugsFood & BeveragesMedical DevicesRadiation-Emitting ProductsTobacco

          FDA Organization
              Center for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Drug Evaluation and ResearchCenter for Food Safety and Applied NutritionCenter for Tobacco ProductsCenter for Veterinary MedicineNational Center for Toxicological ResearchOffice of Regulatory AffairsOffice of the Commissioner

        Topic
              Administrative / ProceduralAdverse Event ReportingAdvertisingAdvisory CommitteesAnimal RuleAntimicrobial ResistanceAquacultureBiopharmaceuticsBiosimilarsBiostatisticsBiotechnologyBovine Spongiform Encephalopathy (BSE)Cellular & Gene TherapyChemistry, Manufacturing, and Controls (CMC)Clinical - AntimicrobialClinical - MedicalClinical - PharmacologyCombination ProductsComplianceCompoundingCurrent Good Manufacturing Practice (CGMP)Drug Competition Action PlanDrug Development ToolsElectronic SubmissionsEmergenciesEnvironmental SafetyExportFDA Amendments Act (FDAAA)FDA Reauthorization Act of 2017 (FDARA)FDA Safety and Innovation Act (FDASIA)Food and Beverage SafetyFood & Drug Administration Modernization Act of 1997Food Safety Modernization Act (FSMA)Generic DrugsGood Clinical Practice (GCP)GUDIDHuman Food SafetyICH-EfficacyICH-MultidisciplinaryICH-QualityICH-SafetyImportIngredientsInspectionInternationalInvestigation & EnforcementInvestigational Device Exemption (IDE)LabelingMicrobiologyNanotechnologyOutbreakOver-the-CounterPackagingPharmaceutical QualityPharmacology / ToxicologyPostmarketPotential Metal or Chemical ContaminantPremarketRare DiseasesReal World Data / Real World Evidence (RWD/RWE)RecallsRecordsRegistrationSafety - Issues, Errors, and ProblemsSanitationTechnology & DisciplineTransportationUDIUser fees

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Summary         Document         Issue Date         FDA Organization         regulated product taxonomy hidden         Topic old hidden         Topic         Guidance Status         Open for Comment         Comment Closing Date on Draft         Docket Number         Guidance Type hidden         center taxonomy hidden         regulated product parent taxonomy hidden

                                                                                  Content current as of:
      01/30/2024Search for FDA Guidance Documents                
                          

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