Guidances directory

All guidance documents2,320 total

• Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Use of Investigational Tobacco Products: Draft Guidance for Industry and InvestigatorsGuidance Document · Center for Tobacco Products
• Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart C : Guidance for Industry and FDA StaffGuidance Document · Office of Regulatory Affairs
• Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Opioid Use Disorder: Developing Depot Buprenorphine Products for TreatmentGuidance Document · Center for Drug Evaluation and Research
• The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory PathwayGuidance Document · Center for Drug Evaluation and Research
• Survey Methodologies to Assess REMS Goals That Relate to KnowledgeGuidance Document · Center for Drug Evaluation and Research
• Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• REMS Assessment: Planning and ReportingGuidance Document · Center for Drug Evaluation and Research
• Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody DetectionGuidance Document · Center for Drug Evaluation and Research
• Developing and Submitting Proposed Draft Guidance Relating to Patient Experience DataGuidance Document · Center for Drug Evaluation and Research
• Labeling of Red Blood Cell Units with Historical Antigen Typing Results: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA StaffGuidance Document · Center for Drug Evaluation and Research
• Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Establishing and Maintaining a List of US Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to ChinaGuidance Document · Human Foods Program
• Guidance for Industry and FDA: Establishing and Maintaining a List of US Dairy Product Manufacturers/Processors with Interest in Exporting to ChileGuidance Document · Human Foods Program
• CVM GFI #243 (VICH GL56) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal PeriodsGuidance Document · Center for Veterinary Medicine
• Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Hypertension: Developing Fixed-Dose Combination Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food RecallsGuidance Document · Human Foods Program
• Testicular Toxicity: Evaluation During Drug DevelopmentGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut ProduceGuidance Document · Human Foods Program
• Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionGuidance Document · Human Foods Program
• Developing Targeted Therapies in Low-Frequency Molecular Subsets of a DiseaseGuidance Document · Center for Drug Evaluation and Research
• Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings : Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review BoardsGuidance Document · Office of the Commissioner
• Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic DrugsGuidance Document · Center for Drug Evaluation and Research
• Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic ApplicationsGuidance Document · Center for Drug Evaluation and Research
• Compliance Policy Guides IndexCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review StaffGuidance Document · Center for Drug Evaluation and Research
• Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product IdentifierGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Determination of Status as a Qualified FacilityGuidance Document · Human Foods Program
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Postapproval Changes to Drug Substances Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live MicrobialsGuidance Document · Human Foods Program
• Allergic Rhinitis: Developing Drug Products for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Nonallergic Rhinitis: Developing Drug Products for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Sample WHO Certificate for Quality of a Pharmaceutical ProductCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Osteoarthritis: Structural Endpoints for the Development of DrugsGuidance Document · Center for Drug Evaluation and Research
• Quality Attribute Considerations for Chewable Tablets Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility RegistrationGuidance Document · Human Foods Program
• Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)Guidance Document · Human Foods Program
• Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco: Guidance for IndustryCompliance Policy Guide (CPG) · Center for Tobacco Products
• Tobacco Retailer Training Programs: Guidance for IndustryGuidance Document · Center for Tobacco Products
• Compliance Policy for Required Warning Statements on Small-Packaged Cigars: Guidance for IndustryGuidance Document · Center for Tobacco Products
• Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Submission of Warning Plans for Cigars: Guidance for IndustryGuidance Document · Center for Tobacco Products
• Elemental Impurities in Drug Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Q3C Tables and List Rev 4Guidance Document · Center for Drug Evaluation and Research
• Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality AssessmentsGuidance Document · Center for Drug Evaluation and Research
• E17 General Principles for Planning and Design of Multi-Regional Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• Use of Electronic Health Record Data in Clinical Investigations Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Innovative Approaches for Nonprescription Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Labeling for Biosimilar Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution ReportingSmall Entity Compliance Guide · Center for Veterinary Medicine
• Major Depressive Disorder: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts LabelsGuidance Document · Human Foods Program
• Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain ProgramGuidance Document · Center for Veterinary Medicine
• Patient-Focused Drug Development: Collecting Comprehensive and Representative InputGuidance Document · Center for Drug Evaluation and Research
• Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Guidance for Industry and Review StaffGuidance Document · Center for Drug Evaluation and Research
• Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Development of a Shared System REMS Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Complicated Urinary Tract Infections: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Small Entity Compliance Guide: Registration of Food FacilitiesSmall Entity Compliance Guide · Human Foods Program
• Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #132 Administrative Applications and the Phased Review ProcessGuidance Document · Center for Veterinary Medicine
• Acne Vulgaris: Establishing Effectiveness of Drugs Intended for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Bioanalytical Method Validation Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent DiseaseGuidance Document · Center for Drug Evaluation and Research
• Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Small Entity Compliance Guide: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules of the FDA Food Safety Modernization ActSmall Entity Compliance Guide · Human Foods Program
• Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on MicrosamplingGuidance Document · Center for Drug Evaluation and Research
• Final In Vivo Bioavailability-Bioequivalence Studies- AnalyticalGuidance Document · Office of Regulatory Affairs
• Complicated Intra-Abdominal Infections: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Menu Labeling Supplemental GuidanceGuidance Document · Human Foods Program
• Clinical Trial Imaging Endpoint Process Standards Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality ConsiderationsGuidance Document · Center for Drug Evaluation and Research
• Chapter 48 7348809A Radioactive Drug Research CommitteeProgram · Office of Regulatory Affairs