Guidances directory

All guidance documents2,828 total

• Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; AvailabilityGuidance Document · Center for Drug Evaluation and Research
• E9 Statistical Principles for Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local AgenciesGuidance Document · Center for Devices and Radiological Health
• Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Environmental Assessment of Human Drug and Biologics Applications: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• 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
• Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific BodyGuidance Document · Human Foods Program
• E5 Ethnic Factors in the Acceptability of Foreign Clinical DataGuidance Document · Center for Drug Evaluation and Research
• Guidance Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical DevicesGuidance Document · Center for Devices and Radiological Health
• 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
• Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review : Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• 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
• Local Anesthetics--Clinical EvaluationGuidance 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 Industry: Guide for Developing and Using Data Bases for Nutrition LabelingManual · Human Foods Program
• 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
• Screening Tests Prior to Study Enrollment: Guidance for Institutional Review Boards and Clinical InvestigatorsInformation Sheet · Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice
• Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical InvestigatorsInformation Sheet · Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice
• Sponsor - Investigator - IRB Interrelationship: Guidance for Institutional Review Boards and Clinical InvestigatorsInformation Sheet · Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice
• Non-local IRB Review : Guidance for Institutional Review Boards and Clinical InvestigatorsInformation Sheet · Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice
• Cooperative Research: Guidance for Institutional Review Boards and Clinical InvestigatorsInformation Sheet · Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice
• Emergency Use of an Investigational Drug or Biologic: Guidance for Institutional Review Boards and Clinical InvestigatorsInformation Sheet · Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice
• Use of Investigational Products When Subjects Enter a Second Institution: Guidance for Institutional Review Boards and Clinical InvestigatorsInformation Sheet · Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice
• 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
• Direct Final Rule Procedures: Guidance for FDA and IndustryGuidance Document · Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Policy
• 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
• Guidance for Industry: Consultation Procedures under FDA's 1992 Statement of Policy for Foods Derived from New Plant VarietiesGuidance Document · Human Foods Program
• 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
• Kit Certification for 510(k)sGuidance Document · Center for Devices and Radiological Health
• 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
• Non-Invasive Blood Pressure (NIBP) Monitor GuidanceGuidance 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
• 510(K) Information Needed for Hydroxyapatite Coated Orthopedic ImplantsGuidance Document · Center for Devices and Radiological Health
• SUPAC-IR Questions and Answers about SUPAC-IR GuidanceGuidance Document · Center for Drug Evaluation and Research
• Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k))Guidance Document · Center for Devices and Radiological Health
• Third Party Review Guidance For Vitreous Aspiration and Cutting 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
• CPG Sec 540.400 Shrimp - Fresh or Frozen, Raw, Headless, Peeled or Breaded (Revoked 12/24/96)Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• 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
• Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer]Guidance 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
• CPG Sec 540.350 Common or Usual Names for Crustaceans (Revoked 8/23/96)Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 540.300 Crabmeat - Product Name (Revoked 8/23/96)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 540.100 Capelin - Prohibited from Being Labeled as Smelt (Revoked 8/23/96)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 110.900 Imported Products - Lack of English LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• Variance from Manufacturer Report Number Format - No. 5Guidance Document · Center for Devices and Radiological Health
• CPG Sec. 654.300 Chloramphenicol as an Unapproved New Animal Drug - Direct Reference Seizure Authority (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 690.600 Rodent Contaminated Pet Foods - *Direct Reference Seizure Authority* (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec 515.200 Malt Extract; Malt Syrup; Malted Cereal Syrup; Liquid Malt; Dried MaltCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 510.700 Fortification of Standardized JuicesCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 510.450 Labeling - Diluted Wines and Cider with Less Than 7% AlcoholCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 505.400 Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles (Labeling)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 500.300 "Approved by FDA" - Use of Phrase Objectionable in Marketing or Labeling of a Food AdditiveCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 500.250 Food Additives - Labeling Directions Necessary for Safe Use: CPG Sec 500.250 Food AdditivesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations