Guidances directory

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All guidance documents2,854 total

Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and MineralsGuidance Document · Human Foods Program
Chapter 2 - BiologicsCompliance Policy Guide (CPG) · Center for Biologics Evaluation and Research
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Adaptive Design Clinical Trials for Drugs and Biologics Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CPG Sec 230150 Blood Donor Classification Statement, Paid or Volunteer DonorCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products: Guidance for IndustryCompliance Policy Guide (CPG) · Center for Tobacco Products
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin ProductsGuidance Document · Center for Drug Evaluation and Research
Transdermal and Topical Delivery Systems - Product Development and Quality ConsiderationsGuidance Document · Center for Drug Evaluation and Research
Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Drug Master Files Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Safety and Performance Based Pathway: Guidance for Industry and Food and Drug AdministrationGuidance Document · Center for Devices and Radiological Health
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
The Special 510(k) Program: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Humanitarian Use Device (HUD) Designations : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Office of the Commissioner
Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Policy Related to Cranberry Products with Added FlavoringsGuidance Document · Human Foods Program
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic SpeciesGuidance Document · Center for Veterinary Medicine
Guidance for Industry: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts LabelsGuidance Document · Human Foods Program
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Child-Resistant Packaging Statements in Drug Product Labeling Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Fabry Disease: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Vulvovaginal Candidiasis: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
Bacterial Vaginosis: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
FMD-145 - Release of the Establishment Inspection Report (EIR)Field Management Directive · Office of Regulatory Affairs
Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #181 Blue Bird Medicated Feed LabelsGuidance Document · Center for Veterinary Medicine
Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Using the Inactive Ingredient Database Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Treatment for Heart Failure: Endpoints for Drug Development Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
E19 OPTIMISATION OF SAFETY DATA COLLECTIONGuidance Document · Center for Drug Evaluation and Research
M10 BIOANALYTICAL METHOD VALIDATIONGuidance Document · Center for Drug Evaluation and Research
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507Guidance Document · Human Foods Program
Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry ProductsGuidance Document · Human Foods Program
Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionGuidance Document · Human Foods Program
CPG Sec 651100 Ethylenediamine Dihydroiodide (EDDI)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review StaffGuidance Document · Center for Drug Evaluation and Research
Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Considerations in Demonstrating Interchangeability With a Reference Product Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Determining Whether to Submit an ANDA or a 505(b)(2) ApplicationGuidance Document · Center for Drug Evaluation and Research
Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and ConsiderationsGuidance Document · Center for Drug Evaluation and Research
Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Clinical Lactation Studies: Considerations for Study DesignGuidance Document · Center for Drug Evaluation and Research
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No 57): Guidance for Industry and Food and Drug AdministrationGuidance Document · Center for Devices and Radiological Health
Policy Clarification for Certain Fluoroscopic Equipment Requirements: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human MilkGuidance Document · Human Foods Program
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles : Guidance for Government Public Health and Emergency Response StakeholdersGuidance Document · Center for Drug Evaluation and Research
Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration StaffGuidance Document · Office of the Commissioner
REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review PracticeGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and AlmondsGuidance Document · Human Foods Program
Rare Diseases: Natural History Studies for Drug Development: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Pediatric HIV Infection: Drug Development for TreatmentGuidance Document · Center for Drug Evaluation and Research
Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure ProphylaxisGuidance Document · Center for Drug Evaluation and Research
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research