Guidances directory

All guidance documents2,320 total

• Cellular Therapy for Cardiac Disease: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• 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: 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
• 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
• 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
• 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
• Q4B Annex 9: Tablet Friability General ChapterGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #192 Anesthetics for Companion AnimalsGuidance Document · Center for Veterinary Medicine
• 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
• 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
• 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
• S6(R1) Addendum: Preclinical Safety Evaluation of Biotechnology: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived PharmaceuticalsGuidance 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
• 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
• Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Pharmaceutical Components at Risk for Melamine Contamination: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Drug-Induced Liver Injury: Premarketing Clinical EvaluationGuidance Document · Center for Drug Evaluation and Research
• Nucleic Acid Testing to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved ApplicationGuidance Document · Center for Drug Evaluation and Research
• ANDAs: Impurities in Drug Substances: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing OperationsSmall Entity Compliance Guide · Center for Veterinary Medicine
• Frequently Asked Questions - IRB Registration: Guidance for Institutional Review Boards (IRBs)Guidance Document · Office of the Commissioner
• Medication Guides — Adding a Toll-Free Number for Reporting Adverse EventsGuidance Document · Center for Drug Evaluation and Research
• Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug ListingGuidance Document · Center for Drug Evaluation and Research
• Presenting Risk Information in Prescription Drug and Medical Device PromotionGuidance Document · Center for Drug Evaluation and Research
• Labeling OTC Human Drug Products; Small Entity Compliance Guide: Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
• CVM GFI #195 Small Entities Compliance Guide For Renderers—Substances Prohibited From Use In Animal Food Or FeedSmall Entity Compliance Guide · Center for Veterinary Medicine
• CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical ProductsGuidance Document · Center for Veterinary Medicine
• Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical DocumentGuidance Document · Center for Drug Evaluation and Research
• Q10 Pharmaceutical Quality SystemGuidance Document · Center for Drug Evaluation and Research
• Q4B Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General ChapterGuidance Document · Center for Drug Evaluation and Research
• Q4B Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General ChapterGuidance Document · Center for Drug Evaluation and Research
• Q4B Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General ChapterGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #149 (VICH GL33) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to TestingGuidance Document · Center for Veterinary Medicine
• Animal Models — Essential Elements to Address Efficacy Under the Animal Rule_09Concept Paper · Center for Drug Evaluation and Research
• Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBsGuidance Document · Office of the Commissioner
• Q4B Annex 3: Test for Particulate Contamination: Subvisible Particles General ChapterGuidance Document · Center for Drug Evaluation and Research
• Labeling OTC Human Drug Products -- Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 540370 Fish and Fishery Products - DecompositionCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held UseGuidance Document · Center for Devices and Radiological Health
• Orally Disintegrating Tablets: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #5 Drug Stability GuidelinesGuidance Document · Center for Veterinary Medicine
• Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• PDUFA Pilot Project: Proprietary Name Review - Concept PaperConcept Paper · Center for Drug Evaluation and Research
• Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBsGuidance Document · Office of the Commissioner
• S1C(R2) Dose Selection for Carcinogenicity Studies of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Animal Models — Essential Elements to Address Efficacy Under the Animal Rule - Concept PaperConcept Paper · Center for Drug Evaluation and Research
• Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Voting Procedures for Advisory Committee Meetings: Guidance for FDA Advisory Committee Members and FDA StaffGuidance Document · Office of the Commissioner
• Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for IndustryGuidance Document · Office of the Commissioner
• Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Intravascular Administration Sets Premarket Notification Submissions [510(k)]: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Surveillance and Detention Without Physical Examination of Condoms: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Q3A(R) Impurities in New Drug SubstancesGuidance Document · Center for Drug Evaluation and Research
• Indexing Structured Product LabelingGuidance Document · Center for Drug Evaluation and Research
• Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health