Guidances directory

All guidance documents2,320 total

• 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
• General Wellness: Policy for Low Risk Devices: 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
• 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
• 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
• Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications DocumentGuidance Document · Center for Drug Evaluation and Research
• 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
• Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations 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
• Postapproval Pregnancy Safety Studies 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
• FDA’s Application of Statutory Factors in Determining When a REMS Is NecessaryGuidance 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
• Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered PlantsGuidance Document · Human Foods Program
• Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic SalmonGuidance Document · Human Foods Program
• Nonproprietary Naming of Biological Products: Update Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional AdulterationGuidance Document · Human Foods Program
• CPG Sec 608200 Prescription Use of Certain Injectable Animal DrugsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 635100 Large Volume Parenterals (LVPs) for Animal UseCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 653100 Animal Grooming AidsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 683100 Action Levels for Aflatoxins in Animal FeedsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Release of ORA Laboratory Analytical Results to the Responsible Party: Guidance for Food and Drug Administration StaffGuidance Document · Office of Inspections and Investigations
• CPG Sec 666100 Alternate Feeding of Different Medicated FeedsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 665300 Use of Type A Medicated Article Proprietary Names in the Names of Medicated FeedsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Enforcement Policy for Certain Marketed Tobacco Products: Draft Guidance for IndustryGuidance Document · Center for Tobacco Products