Guidances directory

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All guidance documents2,854 total

Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New ApplicationsGuidance Document · Center for Drug Evaluation and Research
S7A Safety Pharmacology Studies for Human PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety TrialsGuidance Document · Center for Veterinary Medicine
CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For SubmissionGuidance Document · Center for Veterinary Medicine
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery ProductsGuidance Document · Human Foods Program
Small Entity Compliance Guide: Serving Sizes Reference Amount for Baking Powder, Baking Soda, and PectinSmall Entity Compliance Guide · Human Foods Program
Small Entity Compliance Guide: Safe Handling Statements on Labeling of Shell Eggs and the Refrigeration of Shell Eggs Held for Retail DistributionSmall Entity Compliance Guide · Human Foods Program
Information for Keratome Manufacturers Regarding LASIK - Final Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH StaffGuidance Document · Center for Devices and Radiological Health
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)Guidance Document · Center for Devices and Radiological Health
E10 Choice of Control Group and Related Issues in Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
CVM GFI #85 (VICH GL9) Good Clinical PracticeGuidance Document · Center for Veterinary Medicine
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory: Guidance for Hospitals, Nursing Homes, and Other Health Care FacilitiesGuidance Document · Center for Drug Evaluation and Research
CVM GFI #99 (VICH GL17) Testing of New Biotechnological/Biological ProductsGuidance Document · Center for Veterinary Medicine
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution TestingGuidance Document · Center for Drug Evaluation and Research
CVM GFI #89 (VICH GL6) EIAs for Veterinary Medicinal Products - Phase IGuidance Document · Center for Veterinary Medicine
Monoclonal Antibodies Used as Reagents in Drug ManufacturingGuidance Document · Center for Drug Evaluation and Research
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH StaffGuidance Document · Center for Devices and Radiological Health
Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Clinical Development and Labeling of Anti-Infective Drug ProductsGuidance Document · Center for Drug Evaluation and Research
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