Guidances directory

All guidance documents2,320 total

• Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions: Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Uniform Contraceptive Labeling - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Women and Minorities Guidance RequirementsGuidance Document · Center for Drug Evaluation and Research
• Slit Lamp Guidance - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• CVM GFI #76 Questions and Answers BSE Feed RegulationsSmall Entity Compliance Guide · Center for Veterinary Medicine
• Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act _1Guidance Document · Center for Drug Evaluation and Research
• E5 Ethnic Factors in the Acceptability of Foreign Clinical DataGuidance Document · Center for Drug Evaluation and Research
• 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Providing Clinical Evidence of Effectiveness for Human Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #72 GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDAGuidance Document · Center for Veterinary Medicine
• PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance For The Content Of Premarket Notifications For Esophageal And Tracheal Prostheses - Guidance For IndustryGuidance Document · Center for Devices and Radiological Health
• National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC DrugsGuidance Document · Center for Drug Evaluation and Research
• Q3C: Appendix 5Guidance Document · Center for Drug Evaluation and Research
• Q3C: Appendix 6Guidance Document · Center for Drug Evaluation and Research
• Q3C: Appendix 4Guidance Document · Center for Drug Evaluation and Research
• Third of a series of letters regarding the implementation of the ActIndustry Letter · Center for Drug Evaluation and Research
• Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical StudiesGuidance Document · Center for Drug Evaluation and Research
• Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format)Industry Letter · Center for Drug Evaluation and Research
• Psychoactive Drugs in Infants and Children--Clinical EvaluationGuidance Document · Center for Drug Evaluation and Research
• Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of Colon and Rectal CancerGuidance Document · Center for Drug Evaluation and Research
• Guidance for the Development of Vaginal Contraceptive Drugs (NDA)Guidance Document · Center for Drug Evaluation and Research
• FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung CancerGuidance Document · Center for Drug Evaluation and Research
• Good Laboratory Practice Regulations Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• S1B Testing for Carcinogenicity of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #69 Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing OperationsSmall Entity Compliance Guide · Center for Veterinary Medicine
• CVM GFI #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and DistributorsSmall Entity Compliance Guide · Center for Veterinary Medicine
• CVM GFI #67 Small Entities Compliance Guide for RenderersSmall Entity Compliance Guide · Center for Veterinary Medicine
• Q3C Impurities: Residual Solvents_2011Guidance Document · Center for Drug Evaluation and Research
• Industry-Supported Scientific and Educational ActivitesGuidance Document · Office of the Commissioner
• S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• S6 Preclinical Safety Evaluation of Biotechnology-Derived PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Industry Supported Scientific and Educational Activities: Guidance for IndustryGuidance Document · Office of the Commissioner
• SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo CorrelationsGuidance Document · Center for Drug Evaluation and Research
• Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to ReportGuidance Document · Center for Drug Evaluation and Research
• Dissolution Testing of Immediate Release Solid Oral Dosage FormsGuidance Document · Center for Drug Evaluation and Research
• Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Convenience Kits Interim Regulatory GuidanceGuidance Document · Center for Devices and Radiological Health
• Q2B Validation of Analytical Procedures: MethodologyGuidance Document · Center for Drug Evaluation and Research
• Q1C Stability Testing for New Dosage FormsGuidance Document · Center for Drug Evaluation and Research
• SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Design Control Guidance For Medical Device Manufacturers: Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human UseGuidance Document · Center for Biologics Evaluation and Research
• Proposed Approach to Regulation of Cellular and Tissue-Based ProductsGuidance Document · Center for Biologics Evaluation and Research
• Guidance on Labeling of Foods That Need Refrigeration by ConsumersGuidance Document · Human Foods Program
• Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5Guidance Document · Center for Devices and Radiological Health
• Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k))Guidance Document · Center for Devices and Radiological Health
• General Considerations for the Clinical Evaluation of DrugsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD ProtectionGuidance Document · Center for Devices and Radiological Health
• Identification Labels for Certain Class I Laser Products (Laser Notice 48)Guidance Document · Center for Devices and Radiological Health
• Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49)Guidance Document · Center for Devices and Radiological Health
• Single Dose Acute Toxicity Testing for PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo UseGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 527200 Cheese & Cheese Products - Adulteration with FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585675 Popcorn - Adulteration with Rodent Filth and Field CornCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 505500 Macaroni and Noodle Products - Adulteration Involving Insect Fragments and Rodent HairsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)Memorandum · Center for Biologics Evaluation and Research
• E3 Structure and Content of Clinical Study ReportsGuidance Document · Center for Drug Evaluation and Research
• Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• E4 Dose-Response Information to Support Drug RegistrationGuidance Document · Center for Drug Evaluation and Research
• Effective Visual Control of Laser Projections (Laser Notice 47)Guidance Document · Center for Devices and Radiological Health
• Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV): Memorandum to Registered Blood and Plasma EstablishmentsMemorandum · Center for Biologics Evaluation and Research
• S2A Specific Aspects of Regulatory Genotoxicity Tests for PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Medical Device Reporting for User FacilitiesGuidance Document · Center for Devices and Radiological Health
• Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen: Memorandum to Registered Blood and Plasma EstablishmentsMemorandum · Center for Biologics Evaluation and Research
• Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)Guidance Document · Center for Devices and Radiological Health
• Q1B Photostability Testing of New Drug Substances and ProductsGuidance Document · Center for Drug Evaluation and Research
• S1A The Need for Long-term Rodent Carcinogenicity Studies of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein ProductsGuidance Document · Center for Drug Evaluation and Research
• All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46)Industry Letter · Center for Devices and Radiological Health
• Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated PlasmapheresisMemorandum · Center for Biologics Evaluation and Research
• Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence DocumentationGuidance Document · Center for Drug Evaluation and Research
• User Instruction for Medical Products (Laser Notice 44)Guidance Document · Center for Devices and Radiological Health
• Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen: Memorandum to All Registered Blood EstablishmentsMemorandum · Center for Biologics Evaluation and Research
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled VehiclesGuidance Document · Center for Devices and Radiological Health
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling DevicesGuidance Document · Center for Devices and Radiological Health
• Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise EquipmentGuidance Document · Center for Devices and Radiological Health
• FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological ProductsGuidance Document · Center for Biologics Evaluation and Research
• Topical Dermatologic Corticosteroids: in Vivo BioequivalenceGuidance Document · Center for Drug Evaluation and Research
• Guidance on the Content and Organization of a Premarket Notification for a Medical LaserGuidance Document · Center for Devices and Radiological Health
• Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant ComponentsGuidance Document · Center for Devices and Radiological Health
• Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors: Memorandum to Licensed EstablishmentsMemorandum · Center for Biologics Evaluation and Research
• CPG Sec 550270 Currants - Adulteration Involving Wormy FruitsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550450 Jam, Black Currant - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 480300 Lack of Expiration Date of Stability DataCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 575100 Pesticide Residues in Food and Feed - Enforcement CriteriaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 400100 Drugs, Human - Failure to RegisterCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• Q2A Text on Validation of Analytical ProceduresGuidance Document · Center for Drug Evaluation and Research
• S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution StudiesGuidance Document · Center for Drug Evaluation and Research
• S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity StudiesGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 525825 Vinegar, Definitions - Adulteration with Vinegar EelsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550680 Pineapple, Canned; Pineapple Juice - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations