Guidances directory

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All guidance documents2,854 total

Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)Guidance Document · Center for Drug Evaluation and Research
Providing Regulatory Submissions in Electronic Format; General ConsiderationsGuidance Document · Center for Drug Evaluation and Research
Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/StaffGuidance Document · Center for Devices and Radiological Health
Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary SupplementsSmall Entity Compliance Guide · Human Foods Program
Guidance for Industry: Questions and Answers on HACCP Regulation for Fish and Fishery ProductsGuidance Document · Human Foods Program
CPG Sec. 205.100 Deleted 12/21/98, ObsoleteCompliance Policy Guide (CPG) · Office of Regulatory Affairs
Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems : Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
Variations in Drug Products that May Be Included in a Single ANDAGuidance Document · Center for Drug Evaluation and Research
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance - Version 1 - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
Aqueous Shunts - 510(k) Submissions - Guidance for Industry and for FDA Reviewers/StaffGuidance Document · Center for Devices and Radiological Health
CPG Sec. 675.400 Rendered Animal Feed Ingredients (Withdrawn 4/30/2019)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure: Guidance for Institutional Review Boards and Clinical InvestigatorsGuidance Document · Office of the Commissioner
FDA Animal Products Database Data Entry FormGuidance Document · Center for Devices and Radiological Health
Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement) - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
General/Specific Intended Use - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and VegetablesGuidance Document · Human Foods Program
Noise Claims in Hearing Aid Labeling - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
Guidance Document For Nonprescription Sunglasses - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
Submitting Debarment Certification StatementsGuidance Document · Center for Drug Evaluation and Research
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory CommitteesGuidance Document · Center for Drug Evaluation and Research
Guidance Document for Powered Suction Pump 510(k)s - Guidance for Industry and FDA Reviewers/StaffGuidance Document · Center for Devices and Radiological Health
CPG Sec. 615.100 Extralabel Use of New Animal Drugs in Food Producing Animals - Revoked on 09/24/1998 (63 FR 51074)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
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