Guidances directory

All guidance documents2,828 total

• 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
• Guidance for Industry: Food Security Preventive Measures Guidance for Food Producers, Processors, and TransportersGuidance Document · Human Foods Program
• Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)Guidance Document · Center for Devices and Radiological Health
• Compliance Guide for Cabinet X-Ray SystemsGuidance Document · Center for Devices and Radiological Health
• Non-clinical Information for Femoral Stem Prostheses: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry and FDA: Dear Manufacturer Letter Regarding Sugar Free ClaimsIndustry Letter · Human Foods Program
• Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Pharmacogenomic Data Submissions — Companion GuidanceGuidance Document · Center for Drug Evaluation and Research
• Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs): Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry and Other Stakeholders: Redbook 2000 : Toxicological Principles for the Safety Assessment of Food IngredientsGuidance Document · Human Foods Program
• Redbook 2000: IV.C.8. In-Utero Exposure Phase for Addition to Carcinogenicity Studies or Chronic Toxicity Studies with RodentsGuidance Document · Human Foods Program
• Redbook 2000: IV.C.7. Combined Chronic Toxicity/Carcinogenicity Studies with RodentsGuidance Document · Human Foods Program
• Redbook 2000: IV.C.5.a. Chronic Toxicity Studies with RodentsGuidance Document · Human Foods Program
• Redbook 2000: IV.C.1. Short-Term Tests for Genetic ToxicityGuidance Document · Human Foods Program
• Redbook 2000: III Recommended Toxicity StudiesInformation Sheet · Human Foods Program
• Redbook 2000: I IntroductionGuidance Document · Human Foods Program
• Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid JuicesGuidance Document · Human Foods Program
• Redbook 2000: IV.B.4. Statistical Considerations in Toxicity StudiesGuidance Document · Human Foods Program
• CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and InspectionsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research