Guidances directory

All guidance documents2,320 total

• Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Laser Products - Conformance with IEC 60825-1 Ed 3 and IEC 60601-2-22 Ed 31 (Laser Notice No 56): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray EquipmentGuidance Document · Center for Devices and Radiological Health
• Draft Guidance for Industry: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient StatementsGuidance Document · Human Foods Program
• Draft Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of ProteinGuidance Document · Human Foods Program
• Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Surveying, Leveling, and Alignment Laser Products: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug CarryoverGuidance Document · Center for Veterinary Medicine
• CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health ConcernGuidance Document · Center for Veterinary Medicine
• Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Mpox: Development of Drugs and Biological Products; Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and AnimalsGuidance Document · Human Foods Program
• Format and Content of a REMS Document Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• REMS Document Technical Conformance GuideGuidance Document · Center for Drug Evaluation and Research
• M11 Clinical Electronic Structured Harmonised ProtocolGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Best Practices for Convening a GRAS PanelGuidance Document · Human Foods Program
• Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Pulmonary Tuberculosis: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Homeopathic Drug Products Guidance for FDA Staff and IndustryGuidance Document · Center for Drug Evaluation and Research
• Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer: Guidance for IndustryGuidance Document · Office of the Commissioner
• E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• Statistical Approaches to Establishing BioequivalenceGuidance Document · Center for Drug Evaluation and Research
• Clinical Investigator Administrative Actions - Disqualification: Guidance for Institutional Review Boards, Clinical Investigators, and SponsorsGuidance Document · Office of the Commissioner
• Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Sameness Evaluations in an ANDA — Active IngredientsGuidance Document · Center for Drug Evaluation and Research
• M10 Bioanalytical Method Validation and Study Sample AnalysisGuidance Document · Center for Drug Evaluation and Research
• Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Cross Labeling Oncology Drugs in Combination RegimensGuidance Document · Center for Drug Evaluation and Research
• Expanded Access to Investigational Drugs for Treatment Use: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee ProgramGuidance Document · Center for Drug Evaluation and Research
• Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; AvailabilityGuidance Document · Center for Drug Evaluation and Research
• Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and PreventionGuidance Document · Center for Drug Evaluation and Research
• Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAsGuidance Document · Center for Drug Evaluation and Research
• In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAsGuidance Document · Center for Drug Evaluation and Research
• Human Gene Therapy for Neurodegenerative Diseases: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Multiple Endpoints in Clinical Trials: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based ProductsGuidance Document · Center for Veterinary Medicine
• CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based ProductsGuidance Document · Center for Veterinary Medicine
• Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign GovernmentGuidance Document · Human Foods Program
• Small Entity Compliance Guide: Laboratory Accreditation for Analyses of Foods - What You Need to KnowSmall Entity Compliance Guide · Human Foods Program
• CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated FeedsGuidance Document · Center for Veterinary Medicine
• Tissue Agnostic Drug Development in Oncology: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Guidance for Industry; AvailabilityGuidance Document · Office of the Commissioner
• Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials: Draft Guidance for Industry; AvailabilityGuidance Document · Office of the Commissioner
• ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLAGuidance Document · Center for Drug Evaluation and Research
• Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Competitive Generic TherapiesGuidance Document · Center for Drug Evaluation and Research
• 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
• Clinical Decision Support Software: 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
• Computer Software Assurance for Production and Quality System Software: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• 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 #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for BovinesGuidance Document · Center for Veterinary Medicine