Guidances directory

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All guidance documents2,854 total

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
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
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance PoliciesGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: The Seafood List FDA’s Guide to Determine Acceptable Seafood NamesGuidance Document · Human Foods Program
Informed Consent: Guidance for IRBs, Clinical Investigators, and SponsorsGuidance Document · Office of the Commissioner
Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological ProductsGuidance Document · Office of the Commissioner
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related ImpuritiesGuidance Document · Center for Drug Evaluation and Research
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFARGuidance Document · Center for Drug Evaluation and Research
Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome ReliefGuidance Document · Center for Drug Evaluation and Research
Assessing User Fees Under the Biosimilar User Fee Amendments of 2022: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical QualityGuidance Document · Center for Drug Evaluation and Research
Questions and Answers | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic RiskGuidance Document · Center for Drug Evaluation and Research
Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19 : Guidance for IndustryGuidance Document · Human Foods Program
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy ProductsGuidance Document · Center for Biologics Evaluation and Research
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19: Guidance for IndustryGuidance Document · Human Foods Program
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
Psychedelic Drugs: Considerations for Clinical InvestigationsGuidance Document · Center for Drug Evaluation and Research
Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program: Guidance for Industry, Clinical Laboratories, and Food and Drug Administration StaffGuidance Document · Office of the Commissioner
CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous MediaGuidance Document · Center for Veterinary Medicine
Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Assessing User Fees Under the Generic Drug User Fee Amendments of 2022Guidance Document · Center for Drug Evaluation and Research
Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Nonclinical Evaluation of the Immunotoxic Potential of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Action Level for Inorganic Arsenic in Apple JuiceGuidance Document · Human Foods Program
Migraine: Developing Drugs for Preventive TreatmentGuidance Document · Center for Drug Evaluation and Research
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical InformationGuidance Document · Center for Drug Evaluation and Research
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA RegulationSmall Entity Compliance Guide · Human Foods Program
Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children ActGuidance Document · Center for Drug Evaluation and Research
Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific ConsiderationsGuidance Document · Center for Drug Evaluation and Research
CVM GFI #271 Reporting and Mitigating Animal Drug ShortagesGuidance Document · Center for Veterinary Medicine
Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CPG Sec 555250 DRAFT: Major Food Allergen Labeling and Cross-contactCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene GlycolGuidance Document · Center for Drug Evaluation and Research
Q9(R1) Quality Risk ManagementGuidance Document · Center for Drug Evaluation and Research
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug ProductsGuidance Document · Center for Drug Evaluation and Research