Guidances directory

All guidance documents2,828 total

• CVM GFI #256 - Compounding Animal Drugs from Bulk Drug SubstancesGuidance Document · Center for Veterinary Medicine
• Guidance for Industry: Policy Regarding N-acetyl-L-cysteineGuidance Document · Human Foods Program
• Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings: Guidance for IndustryGuidance Document · Office of the Commissioner
• General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Orange Book Questions and Answers Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Evaluation of Therapeutic EquivalenceGuidance Document · Center for Drug Evaluation and Research
• Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for AnimalsGuidance Document · Center for Veterinary Medicine
• Identifying Trading Partners Under the Drug Supply Chain Security ActGuidance Document · Center for Drug Evaluation and Research
• Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for IndustryGuidance Document · Office of the Commissioner
• Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for IndustryGuidance Document · Office of the Commissioner
• Considerations for Rescinding Breakthrough Therapy DesignationGuidance Document · Center for Drug Evaluation and Research
• Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology ConsiderationsGuidance Document · Center for Drug Evaluation and Research
• FDA Oversight of Food Covered by Systems Recognition ArrangementsGuidance Document · Human Foods Program
• Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Fish and Fishery Products Hazards and ControlsGuidance Document · Human Foods Program
• Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Clinical/MedicalGuidance Document · Center for Drug Evaluation and Research
• Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance GuideGuidance Document · Center for Drug Evaluation and Research
• Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market NotificationGuidance Document · Human Foods Program
• Risk Management Plans to Mitigate the Potential for Drug ShortagesGuidance Document · Center for Drug Evaluation and Research
• Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication ErrorsGuidance Document · Center for Drug Evaluation and Research
• Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for SproutingGuidance Document · Human Foods Program
• CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing AnimalsGuidance Document · Center for Veterinary Medicine
• Benefit-Risk Considerations for Product Quality AssessmentsGuidance Document · Center for Drug Evaluation and Research
• Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Infant Formula Enforcement Discretion PolicyGuidance Document · Human Foods Program
• Electronic Submission of IND Safety Reports Technical Conformance Guide : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards CompatibilityGuidance Document · Center for Drug Evaluation and Research
• E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards CompatibilityGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification ProgramGuidance Document · Human Foods Program
• Ulcerative Colitis: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Crohn’s Disease: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Providing Submissions in Electronic Format — Postmarketing Safety ReportsGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: Action Levels for Lead in JuiceGuidance Document · Human Foods Program
• Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers RegulationGuidance Document · Human Foods Program
• Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free DietGuidance Document · Center for Drug Evaluation and Research
• Bioavailability Studies Submitted in NDAs or INDs – General ConsiderationsGuidance Document · Center for Drug Evaluation and Research
• Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Reconditioning of Fish and Fishery Products by SegregationGuidance Document · Human Foods Program
• Surgical Sutures - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription DrugsGuidance Document · Center for Drug Evaluation and Research
• E8(R1) General Considerations for Clinical StudiesGuidance Document · Center for Drug Evaluation and Research
• Chronic Hepatitis B Virus Infection: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain ProvisionsGuidance Document · Human Foods Program
• Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA StaffGuidance Document · Office of Inspections and Investigations
• Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Inclusion of Older Adults in Cancer Clinical Trials: Guidance for IndustryGuidance Document · Office of the Commissioner
• Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Pre-Launch Activities Importation Requests (PLAIR): Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Patient-Focused Drug Development: Methods to Identify What Is Important to Patients: Guidance for Industry, Food and Drug Administration Staff, and Other StakeholdersGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry and FDA Staff: Model Accreditation Standards for Third-Party Certification Body Accreditation for Food Safety AuditsGuidance Document · Human Foods Program
• Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Drug Product Tracing: The Effect of Section 585 of the FD&C ActGuidance Document · Center for Drug Evaluation and Research
• Population Pharmacokinetics: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph DrugsGuidance Document · Center for Drug Evaluation and Research
• Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other StakeholdersGuidance Document · Center for Devices and Radiological Health
• Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other StakeholdersGuidance Document · Center for Devices and Radiological Health
• Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Good ANDA Submission Practices Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #159 (VICH GL36) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADIGuidance Document · Center for Veterinary Medicine
• Collecting and Providing 702(b) Portions of FDA Official Samples: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Pathology Peer Review in Nonclinical Toxicology Studies: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization ActGuidance Document · Human Foods Program
• Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization ActGuidance Document · Human Foods Program
• Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization ActGuidance Document · Human Foods Program
• Inspection of Injectable Products for Visible Particulates: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products : Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Development of Anti-Infective Drug Products for the Pediatric Population : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual ReportsGuidance Document · Center for Drug Evaluation and Research
• IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Tobacco Product User Fees: Responses to Frequently Asked QuestionsGuidance Document · Center for Tobacco Products
• Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators : Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Guidance for Industry: Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of IdentityGuidance Document · Human Foods Program
• Guidance for Industry: Preparation of Food Contact Substance Notifications (Toxicology Recommendations)Guidance Document · Human Foods Program
• Guidance for Industry: Preparation of Food Contact Substance Notifications (Administrative)Guidance Document · Human Foods Program
• Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared FoodsGuidance Document · Human Foods Program
• Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal DrugsGuidance Document · Center for Veterinary Medicine
• Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal DrugsGuidance Document · Center for Veterinary Medicine