Guidances directory

All guidance documents2,320 total

• Q2(R2) Validation of Analytical ProceduresGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary SupplementsGuidance Document · Human Foods Program
• Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review BoardsGuidance Document · Center for Drug Evaluation and Research
• Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Foods Derived from Plants Produced Using Genome EditingGuidance Document · Human Foods Program
• Charging for Investigational Drugs Under an IND: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Use of Data Monitoring Committees in Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C ActGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPEGuidance Document · Human Foods Program
• Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C ActGuidance Document · Center for Drug Evaluation and Research
• Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell ProductsGuidance Document · Center for Biologics Evaluation and Research
• CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of DataGuidance Document · Center for Veterinary Medicine
• CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary MedicineGuidance Document · Center for Veterinary Medicine
• Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical ProductsGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human FoodGuidance Document · Human Foods Program
• Human Gene Therapy Products Incorporating Human Genome Editing: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal ProductsGuidance Document · Center for Veterinary Medicine
• Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginGuidance Document · Center for Drug Evaluation and Research
• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Reformulating Drug Products That Contain Carbomers Manufactured With BenzeneGuidance Document · Center for Drug Evaluation and Research
• Potency Assurance for Cellular and Gene Therapy ProductsGuidance Document · Center for Biologics Evaluation and Research
• Quality Considerations for Topical Ophthalmic Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Rare Diseases: Considerations for the Development of Drugs and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Digital Health Technologies for Remote Data Acquisition in Clinical InvestigationsGuidance Document · Center for Drug Evaluation and Research
• Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor SpeciesGuidance Document · Center for Veterinary Medicine
• Master Protocols for Drug and Biological Product DevelopmentGuidance Document · Center for Drug Evaluation and Research
• Data Standards for Drug and Biological Product Submissions Containing Real-World Data: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use AuthorizationGuidance Document · Center for Drug Evaluation and Research
• Clinical Pharmacology Considerations for Peptide Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Draft Guidance for Industry: Menu Labeling Supplemental Guidance (Edition 2)Guidance Document · Human Foods Program
• Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and AdvertisementsGuidance Document · Center for Drug Evaluation and Research
• Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #199 Animal Generic Drug User Fees and Fee Waivers and ReductionsGuidance Document · Center for Veterinary Medicine
• Small Entity Compliance Guide: Milk and Cream Products and Yogurt Products; Final Rule to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for YogurtSmall Entity Compliance Guide · Human Foods Program
• COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Translation of Good Laboratory Practice Study Reports: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product ListingGuidance Document · Office of the Commissioner
• Real-Time Oncology Review (RTOR) : Guidance for IndustryGuidance Document · Office of the Commissioner
• Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response TheoryGuidance Document · Center for Drug Evaluation and Research
• Submitting Patient-Reported Outcome Data in Cancer Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring FacilitiesGuidance Document · Center for Drug Evaluation and Research
• Topical Dermatologic Corticosteroids: In Vivo BioequivalenceGuidance Document · Center for Drug Evaluation and Research
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Development and Licensure of Vaccines to Prevent COVID-19: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Revised): Guidance for IndustryGuidance Document · Center for Tobacco Products
• Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 (Revised): Guidance for IndustryGuidance Document · Center for Tobacco Products
• Benefit-Risk Assessment for New Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4)Guidance Document · Human Foods Program
• Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Stimulant Use Disorders: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”Guidance Document · Center for Drug Evaluation and Research
• Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human ConsumptionGuidance Document · Human Foods Program
• Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or TreatmentGuidance Document · Office of the Commissioner
• Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human ConsumptionGuidance Document · Human Foods Program
• CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing AnimalsGuidance Document · Center for Veterinary Medicine
• Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending ApplicationsGuidance Document · Center for Drug Evaluation and Research
• Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA ProductsGuidance Document · Center for Drug Evaluation and Research
• Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health EmergenciesGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human RemainsGuidance Document · Human Foods Program
• Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory EvidenceGuidance Document · Center for Drug Evaluation and Research
• Regulatory Considerations for Prescription Drug Use-Related SoftwareGuidance Document · Center for Drug Evaluation and Research
• Labeling for Biosimilar and Interchangeable Biosimilar ProductsGuidance Document · Center for Drug Evaluation and Research
• Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1): Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion AnimalsGuidance Document · Center for Veterinary Medicine
• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products: Guidance for IRBs and Clinical InvestigatorsGuidance Document · Center for Drug Evaluation and Research
• Endogenous Cushing’s Syndrome: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance PoliciesGuidance Document · Center for Drug Evaluation and Research
• Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (*Revised): Guidance for IndustryGuidance Document · Center for Tobacco Products
• Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research