Guidances directory

All guidance documents2,320 total

• 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
• Classification Categories for Certain Supplements Under BsUFA IIIGuidance Document · Center for Drug Evaluation and Research
• 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
• QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for IndustryGuidance Document · Office of the Commissioner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
• Patient-Matched Guides to Orthopedic Implants: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G 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
• E6(R3) GOOD CLINICAL PRACTICE (GCP)Guidance 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
• Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022Guidance Document · Center for Drug Evaluation and Research
• S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #108 Registering with CVM’s Electronic Submission SystemGuidance Document · Center for Veterinary Medicine
• Acute Radiation Syndrome: Developing Drugs for Prevention and TreatmentGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Transition from Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionGuidance Document · Human Foods Program
• Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #170 Animal Drug User Fees and Fee Waivers and ReductionsGuidance Document · Center for Veterinary Medicine
• Over-the-Counter Monograph Order Requests: Format and ContentGuidance Document · Center for Drug Evaluation and Research
• Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-MakingGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug AdministrationGuidance Document · Human Foods Program
• Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments: Guidance for IndustryGuidance Document · Center for Tobacco Products
• CVM GFI #281 Infectious Otitis Externa Drugs for Topical Use in DogsGuidance Document · Center for Veterinary Medicine
• Tobacco Health Document Submission (Revised): Guidance for IndustryGuidance Document · Center for Tobacco Products
• Identification of Medicinal Products — Implementation and UseGuidance Document · Center for Drug Evaluation and Research
• Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and SponsorsGuidance Document · Office of the Commissioner
• Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food LabelingGuidance Document · Human Foods Program
• Clinical Trial Considerations to Support Accelerated Approval of Oncology TherapeuticsGuidance Document · Office of the Commissioner
• Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance Guide: Guidance for IndustrySmall Entity Compliance Guide · Center for Tobacco Products
• Pharmacogenomic Data SubmissionsGuidance Document · Center for Drug Evaluation and Research
• Prohibition of Distributing Free Samples of Tobacco Products: Guidance for IndustryGuidance Document · Center for Tobacco Products
• Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops: Guidance for IndustryGuidance Document · Center for Tobacco Products
• FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for IndustrySmall Entity Compliance Guide · Center for Tobacco Products
• Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for IndustryGuidance Document · Center for Tobacco Products
• Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order: Guidance for Tobacco RetailersGuidance Document · Center for Tobacco Products
• Listing of Ingredients in Tobacco Products: Guidance for IndustryGuidance Document · Center for Tobacco Products
• Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #106 The Use of Published Literature in Support of New Animal Drug ApprovalsGuidance Document · Center for Veterinary Medicine
• Guidance for Industry: Frequently Asked Questions About Medical Foods - Third EditionGuidance Document · Human Foods Program
• Development of Local Anesthetic Drug Products With Prolonged Duration of EffectGuidance Document · Center for Drug Evaluation and Research
• Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Labeling of Infant FormulaGuidance Document · Human Foods Program
• Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral PathogensGuidance Document · Center for Drug Evaluation and Research
• Q13 Continuous Manufacturing of Drug Substances and Drug Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Neovascular Age-Related Macular Degeneration: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 102030, 102031, 102032, 102033); Small Entity Compliance GuideGuidance Document · Center for Devices and Radiological Health