Guidances directory

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All guidance documents2,854 total

Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Adminstration Amendments Act of 2007 - AppendixGuidance Document · Human Foods Program
Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007Guidance Document · Human Foods Program
Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection ActGuidance Document · Human Foods Program
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
Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical DevicesGuidance Document · Human Foods Program
Medication Guides — Adding a Toll-Free Number for Reporting Adverse EventsGuidance Document · Center for Drug Evaluation and Research
Small Entity Compliance Guide: Bottled Water and Residual Disinfectants and Disinfection ByproductsSmall Entity Compliance Guide · Human Foods Program
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
Small Entity Compliance Guide: Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and OsteoporosisSmall Entity Compliance Guide · Human Foods Program
Labeling OTC Human Drug Products; Small Entity Compliance Guide: Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
CPG Sec 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Inspections and Investigations Human Foods Program
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
Small Entity Compliance Guide: Declaration by Name on the Label of All Foods and Cosmetic Products that Contain Cochineal Extract and CarmineSmall Entity Compliance Guide · Human Foods Program
Questions and Answers on Current Good Manufacturing Practice Questions and Answers on Current Good Manufacturing Practice Requirements | General ProvisionsGuidance Document · Center for Drug Evaluation and Research
Small Entity Compliance Guide: Bottled Water and UraniumSmall Entity Compliance Guide · Human Foods Program
Small Entity Compliance Guide: Bottled Water and ArsenicSmall Entity Compliance Guide · Human Foods Program
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
Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive PetitionsGuidance Document · Human Foods Program
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
Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an IngredientGuidance Document · Human Foods Program
Guidance for Industry: 1991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as Part of the Weight of Frozen SeafoodIndustry Letter · Human Foods Program
Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade AssociationGuidance Document · Human Foods Program
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule_09Concept Paper · Center for Drug Evaluation and Research
Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health ClaimsGuidance Document · Human Foods Program
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
Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic ActGuidance Document · Human Foods Program
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
Guidance for Industry: Dear Manufacturer Letter Regarding Front-of-Package SymbolsIndustry Letter · Human Foods Program
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
CPG Sec 540.575 Fish - Fresh and Frozen - Adulteration Involving Decomposition (Withdrawn 7/18/2008)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
Small Entity Compliance Guide: Nutrient Content Claims Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional FoodsSmall Entity Compliance Guide · Human Foods Program
Small Entity Compliance Guide: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable RiskSmall Entity Compliance Guide · Human Foods Program
Small Entity Compliance Guide: Standard of Identity for White ChocolateSmall Entity Compliance Guide · Human Foods Program
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
CPG Sec 560.700 - Processing of Imported Frozen Products of Multiple Sizes (e.g., Shrimp, Prawns, Etc.) (Withdrawn 6/6/2008)Compliance Policy Guide (CPG) · Human Foods Program
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
Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
E15 Pharmacogenomics Definitions and Sample CodingGuidance Document · Center for Drug Evaluation and Research
Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and SponsorsGuidance Document · Center for Biologics Evaluation and Research
Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part IGuidance Document · Human Foods Program
CPG Sec 500500 Guidance Levels for 3-MCPD (3-chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style SaucesCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Q4B Annex I: Residue on Ignition/Sulphated Ash General ChapterGuidance Document · Center for Drug Evaluation and Research
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation RegionsGuidance Document · Center for Drug Evaluation and Research
Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
CPG Sec 555.320 Listeria monocytogenesCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
Medical Glove Guidance Manual: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #179 Use of Animal Clones and Clone Progeny for Human Food and Animal FeedGuidance Document · Center for Veterinary Medicine
The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
CPG Sec 575100 Draft Revision - Pesticide Chemical Residues in Food - Enforcement CriteriaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations)Guidance Document · Human Foods Program
Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review StaffGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #92 (VICH GL10(R)) Impurities In New Veterinary Drug SubstancesGuidance Document · Center for Veterinary Medicine
Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #93 (VICH GL11(R)) Impurities in New Veterinary Medicinal ProductsGuidance Document · Center for Veterinary Medicine
CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances and Medicinal ProductsGuidance Document · Center for Veterinary Medicine
Considerations for Plasmid DNA Vaccines for Infectious Disease Indications: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Role of HIV Drug Resistance Testing in Antiretroviral Drug DevelopmentGuidance Document · Center for Drug Evaluation and Research
Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and TestsGuidance Document · Center for Devices and Radiological Health,Office of Product Evaluation and Quality,Office of In Vitro Diagnostics and Radiological Health
Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment AGuidance Document · Center for Devices and Radiological Health,Office of Product Evaluation and Quality,Office of In Vitro Diagnostics and Radiological Health
Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Food Security Preventive Measures Guidance for Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk ProcessorsGuidance Document · Human Foods Program
Guidance for Industry: Food Security Preventive Measures Guidance for Retail Food Stores and Food Service EstablishmentsGuidance Document · Human Foods Program
Guidance for Industry: Food Security Preventive Measures for Importers and FilersGuidance Document · Human Foods Program
CVM GFI #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease ClaimsGuidance Document · Center for Veterinary Medicine