Guidances directory

All guidance documents2,828 total

• PHS Guideline on Infectious Disease Issues in Xenotransplantation: PHS GuidelineGuidance Document · Center for Biologics Evaluation and Research
• Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA ReviewersGuidance Document · Center for Devices and Radiological Health
• Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesGuidance Document · Center for Drug Evaluation and Research Center for Biologics Evaluation and Research
• Labeling OTC Human Drug Products Using a Column FormatGuidance Document · Center for Drug Evaluation and Research
• E11 Clinical Investigation of Medicinal Products in the Pediatric PopulationGuidance Document · Center for Drug Evaluation and Research
• Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Channels of Trade Policy for Commodities with Methyl Parathion ResiduesGuidance Document · Human Foods Program
• Use of Sterile Connecting Devices in Blood Bank Practices: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Guidance Document for Dura Substitute Devices - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Submitting and Reviewing Complete Responses to Clinical Holds (Revised)Guidance Document · Center for Drug Evaluation and Research
• Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products Questions and Answers: Guidance for Industry Q&AGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 230.110- Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood ProductsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Labeling for Electronic Anti-Theft Systems: Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• E12A Principles for Clinical Evaluation of New Antihypertensive DrugsGuidance Document · Center for Drug Evaluation and Research
• Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 - Guidance for Industry and for FDA ReviewersGuidance Document · Center for Devices and Radiological Health
• Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• CPG Sec 515700 Chocolate & Chocolate Liquor - Adulteration with Insect and Rodent FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting ChangesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal FeedGuidance Document · Human Foods Program
• CPG Sec. 220.100 - IS Shipment Biologicals for Medical EmergencyCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/StaffGuidance Document · Center for Devices and Radiological Health
• 1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH ReviewersGuidance Document · Center for Devices and Radiological Health
• Redbook 2000: IV.C.9.b. Guidelines for Developmental Toxicity StudiesGuidance Document · Human Foods Program
• Redbook 2000: IV.C.9.a.Guidelines for Reproduction StudiesGuidance Document · Human Foods Program
• Redbook 2000: IV.C.1.d. Mammalian Erythrocyte Micronucleus TestGuidance Document · Human Foods Program
• Redbook 2000: IV.C.1.a. Bacterial Reverse Mutation TestGuidance Document · Human Foods Program
• Redbook 2000: IV.C.10. Neurotoxicity StudiesGuidance Document · Human Foods Program
• Redbook 2000: IV.B.3. Pathology Considerations in Toxicity StudiesGuidance Document · Human Foods Program
• CPG Sec. 100.950 International Partnership Agreements for Compliance ActivitiesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CVM GFI #98 Dioxin In Anti-Caking Agents In Animal Feed And Feed IngredientsGuidance Document · Center for Veterinary Medicine
• Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Street Drug AlternativesGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 215.100 IND Filings; Completion of Applicable Portions Prior to Final Action on License Applications or License Supplements, Deleted 03/28/2000, Outdated and ObsoleteCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic ActCenter for Drug Evaluation and Research
• Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers: Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• CPG Sec. 252.110 Volume Limits for Automated Collection of Source Plasma (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CVM GFI #91 (VICH GL8) Stability Testing for Medicated PremixesGuidance Document · Center for Veterinary Medicine
• Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/StaffGuidance Document · Center for Devices and Radiological Health
• NDAs: Impurities in Drug SubstancesGuidance Document · Center for Drug Evaluation and Research
• Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer: Guidance for Industry and for FDA ReviewersGuidance Document · Center for Devices and Radiological Health
• Guidance for the Content of Premarket Notifications for Penile Rigidity Implants - Guidance for Industry and for FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA StaffGuidance Document · Center for Devices and Radiological Health
• Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA ReviewersGuidance Document · Center for Devices and Radiological Health
• Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000Guidance Document · Center for Drug Evaluation and Research
• Applications Covered by Section 505(b)(2)Guidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Seafood HACCP Transition GuidanceGuidance Document · Human Foods Program
• Drug Master Files for Bulk Antibiotic Drug Substances: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Submission of Abbreviated Reports and Synopses in Support of Marketing ApplicationsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #75 (VICH GL5) Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal ProductsGuidance Document · Center for Veterinary Medicine
• CVM GFI #74 (VICH GL4 ) Stability Testing of New Veterinary Dosage FormsGuidance Document · Center for Veterinary Medicine
• Possible Dioxin/PCB Contamination of Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Consumer-Directed Broadcast Advertisements: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 230140 Evaluation and Processing Post Donation Information Reports is obsolete and was withdrawn on 7/16/2018Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Antimicrobial Food AdditivesGuidance Document · Human Foods Program
• S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)Guidance Document · Center for Drug Evaluation and Research
• Guidance Document for Powered Muscle Stimulator 510(k)s - Guidance for Industry, FDA Reviewers/Staff and ComplianceGuidance Document · Center for Devices and Radiological Health
• Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee ActGuidance Document · Center for Drug Evaluation and Research
• Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Recommended Clinical Study Design for Ventricular Tachycardia AblationGuidance Document · Center for Devices and Radiological Health
• Immunotoxicity Testing GuidanceGuidance Document · Center for Devices and Radiological Health
• CPG Sec. 210.100 Deleted 4/26/99, Outdated and ObsoleteCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Guidance on 510(k) Submissions for Keratoprostheses - Guidance for Industry and for FDA Reviewers/StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Dermabrasion Devices - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh - Guidance for Industry and/or for FDA Reviewers/Staff and/or ComplianceGuidance Document · Center for Devices and Radiological Health
• For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products: Guidance for Industry:Guidance Document · Center for Biologics Evaluation and Research
• 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