Guidances directory

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All guidance documents2,854 total

Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
User Fees and Refunds for Premarket Notification Submissions (510(k)s): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
User Fees for 513(g) Requests for Information: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Size, Shape, and Other Physical Attributes of Generic Tablets and CapsulesGuidance Document · Center for Drug Evaluation and Research
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement DiscretionGuidance Document · Human Foods Program
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBsGuidance Document · Office of the Commissioner
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
How To Obtain a Covered Product AuthorizationGuidance Document · Center for Drug Evaluation and Research
Q3D(R2) – Guideline for Elemental Impurities: International Council for Harmonisation; Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug ProductsGuidance Document · Center for Drug Evaluation and Research
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug ProductsGuidance Document · Center for Drug Evaluation and Research
Meetings with Industry and Investigators on the Research and Development of Tobacco Products (Revised): Guidance for Industry and InvestigatorsGuidance Document · Center for Tobacco Products
Policy for Monkeypox Tests to Address the Public Health Emergency: Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological ProductsGuidance Document · Center for Drug Evaluation and Research
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention StudiesGuidance Document · Center for Tobacco Products
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallusGuidance Document · Center for Veterinary Medicine
CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for EquinesGuidance Document · Center for Veterinary Medicine
CVM GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for CaninesGuidance Document · Center for Veterinary Medicine
CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for PorcinesGuidance Document · Center for Veterinary Medicine
CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for FelinesGuidance Document · Center for Veterinary Medicine
Guidance for Industry: Questions and Answers Regarding the Final Rule on Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House)Guidance Document · Human Foods Program
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
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) 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
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