Guidances directory

Complete index, 2,854 entries. Search and filter guidances →

All guidance documents2,854 total

E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification SubmissionsGuidance Document · Center for Drug Evaluation and Research
PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance GuideSmall Entity Compliance Guide · Center for Drug Evaluation and Research
Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Q4B Annex 7 (R2): Dissolution Test General ChapterGuidance Document · Center for Drug Evaluation and Research
Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective: Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Submission of Summary Bioequivalence Data for Abbreviated New Drug ApplicationsGuidance Document · Center for Drug Evaluation and Research
Dosage Delivery Devices for Orally Ingested OTC Liquid Drug ProductsGuidance Document · Center for Drug Evaluation and Research
How to Write a Request for Designation (RFD): Guidance for IndustryGuidance Document · Office of the Commissioner
Influenza: Developing Drugs for Treatment and/or ProphylaxisGuidance Document · Center for Drug Evaluation and Research
Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
"Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type); : Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition ProcessGuidance Document · Human Foods Program
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug ProductsGuidance Document · Center for Drug Evaluation and Research
Hypertension Indication: Drug Labeling for Cardiovascular Outcome ClaimsGuidance Document · Center for Drug Evaluation and Research
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug ProductsCenter for Drug Evaluation and Research
Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Letter to Firms that Grow, Harvest, Sort, Pack, or Ship Fresh CilantroIndustry Letter · Human Foods Program
CPG Sec 335700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference SeizureCompliance Policy Guide (CPG) · Center for Devices and Radiological Health
Sample formats for Form FDA 356h_2011Guidance Document · Center for Drug Evaluation and Research
Process Validation: General Principles and Practices: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry:Guidance Document · Center for Biologics Evaluation and Research
CPG Sec 527300 Microbial Contaminants & Alkaline Phosphatase ActivityCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary SupplementsSmall Entity Compliance Guide · Human Foods Program
CPG Sec 510.800 Beverages-Serving Size LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
“Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CPG Sec 527300 Dairy Products - Microbial Contaminants & Alkaline Phosphatase ActivityCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Antibacterial Drug Products: Use of Noninferiority Studies to Support ApprovalGuidance Document · Center for Drug Evaluation and Research
ANDAs: Impurities in Drug Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Blood Lancet Labeling - Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Safety of Imported Traditional Pottery Intended for Use with Food and the Use of the Term "Lead Free" in the Labeling of Pottery/Proper Identification of Ornamental and Decorative CeramicwareGuidance Document · Human Foods Program
Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Cellular Therapy for Cardiac Disease: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Guidance for Industry: Food Additive Petition Expedited ReviewGuidance Document · Human Foods Program
Addition of URLs to Electronic Product Labeling: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Q4B Annex 10: Polyacrylamide Gel Electrophoresis General ChapterGuidance Document · Center for Drug Evaluation and Research
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 11: Capillary Electrophoresis General ChapterGuidance Document · Center for Drug Evaluation and Research
Impact-Resistant Lenses: Questions and Answers: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 12: Analytical Sieving General ChapterGuidance Document · Center for Drug Evaluation and Research
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance GuideSmall Entity Compliance Guide · Center for Drug Evaluation and Research
Contact Lens Care Products Labeling: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls InformationGuidance Document · Center for Veterinary Medicine
Label Comprehension Studies for Nonprescription Drug ProductsGuidance Document · Center for Drug Evaluation and Research
Radioactive Drug Research Committee: Human Research Without An Investigational New Drug ApplicationGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal FeedGuidance Document · Center for Veterinary Medicine Human Foods Program
Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices for Enzyme PreparationsGuidance Document · Human Foods Program
In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Systemic Lupus Erythematosus --Developing Medical Products for TreatmentGuidance Document · Center for Drug Evaluation and Research
Individual Product Bioequivalence Recommendations for Specific ProductsGuidance Document · Center for Drug Evaluation and Research
Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products: Guidance for Industry and FDA StaffGuidance Document · Center for Tobacco Products
Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBsInformation Sheet · Office of the Commissioner
FDA Inspections of Clinical Investigators: Guidance For IRBs, Clinical Investigators, and SponsorsInformation Sheet · Office of the Commissioner
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)Guidance Document · Human Foods Program
Orientación preliminar de la industria: Preguntas y respuestas sobre el Registro de productos sanitarios en productos agroalimentarios, según establecido por la Ley de Enmiendas a la Alimentación y Medicamentos (FDA), 2007 (Edición 2)Guidance Document · Human Foods Program
Guide pour l’industrie: Questions et réponses concernant le Registre de denrées alimentaires à signaler Reportable Food Registry (RFR) tel qu’établi par le Food and Drug Administration Amendments Act de 2007 (FDAAA) (2ème édition)Guidance Document · Human Foods Program
Chinese Translation of Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答 2010年5月)Guidance Document · Human Foods Program
Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water AdvisoryGuidance Document · Human Foods Program
Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco: Guidance for Industry and FDA StaffGuidance Document · Center for Tobacco Products
Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Guidance for Industry: Sanitary Transportation of FoodGuidance Document · Human Foods Program
Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and StorageSmall Entity Compliance Guide · Human Foods Program
Q4B Annex 9: Tablet Friability General ChapterGuidance Document · Center for Drug Evaluation and Research
Small Entity Compliance Guide: Bottled Water and Total Coliform and E. coliSmall Entity Compliance Guide · Human Foods Program
Guidance for Industry: Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007Guidance Document · Human Foods Program
Orientación preliminar para la industria: Presentación de Informe para múltiples instalaciones al Portal electrónico de incidentesGuidance Document · Center for Veterinary Medicine Human Foods Program
French Translation of Guidance for Industry: Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal (Soumission d’un rapport concernant plusieurs usines auprès du portail électronique d’enregistrement des denrées alimentaires)Guidance Document · Center for Veterinary Medicine Human Foods Program
CVM GFI #192 Anesthetics for Companion AnimalsGuidance Document · Center for Veterinary Medicine
CPG Sec 540.375 Canned Salmon - Adulteration Involving Decomposition (Withdrawn 3/22/2010)Compliance Policy Guide (CPG) · Office of Inspections and Investigations
S9 Nonclinical Evaluation for Anticancer PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive SafetyGuidance Document · Human Foods Program
Chinese Translation of Guidance for Industry: Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal (行业指南：向美国食规定的应通报食品门户网提交多个机构的报告)Guidance Document · Center for Veterinary Medicine Human Foods Program
Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for IndustryGuidance Document · Office of the Commissioner
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version)Guidance Document · Center for Devices and Radiological Health
Guidance for the Use of Bayesian Statistics in Medical Device Clinical TrialsGuidance Document · Office of the Commissioner,Office of Clinical Policy and Programs
Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP): Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products: Guidance for IndustryGuidance Document · Office of the Commissioner
General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2): Guidance to Industry and FDA StaffGuidance Document · Center for Tobacco Products
Q4B Annex 5: Disintegration Test General ChapterGuidance Document · Center for Drug Evaluation and Research
Q4B Annex 8: Sterility Test General ChapterGuidance Document · Center for Drug Evaluation and Research
PET Drug Products - Current Good Manufacturing Practice (CGMP)Guidance Document · Center for Drug Evaluation and Research
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Residual Solvents in Drug Products Marketed in the United States: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Q8(R2) Pharmaceutical DevelopmentGuidance Document · Center for Drug Evaluation and Research
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
SPL Standard for Content of Labeling Technical Qs & AsGuidance Document · Center for Drug Evaluation and Research
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Letter Regarding Point of Purchase Food LabelingIndustry Letter · Human Foods Program
Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing InformationGuidance Document · Center for Drug Evaluation and Research
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Manufacturers, Retailers, Importers and FDA StaffGuidance Document · Center for Tobacco Products
End-of-Phase 2A MeetingsGuidance Document · Center for Drug Evaluation and Research
Chinese Translation of the Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答)Guidance Document · Human Foods Program
Preguntas y respuestas sobre el Registro de incidentes sanitarios en productos agroalimentarios, según lo establecido por la Ley de Enmiendas de la Administración de Medicamentos y Alimentos de 2007Guidance Document · Human Foods Program
French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler)Guidance Document · Human Foods Program