Guidances directory

All guidance documents2,320 total

• Guidance for Industry: Highly Concentrated Caffeine in Dietary SupplementsGuidance Document · Human Foods Program
• Special Protocol Assessment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric PopulationGuidance Document · Center for Drug Evaluation and Research
• Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling DocumentationGuidance Document · Center for Drug Evaluation and Research
• Chronic Obstructive Pulmonary Disease: Use of the St George’s Respiratory Questionnaire as a PRO Assessment Tool Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live AnimalsGuidance Document · Human Foods Program
• Standardization of Data and Documentation Practices for Product Tracing Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• E18 Genomic Sampling and Management of Genomic Data Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 1030)Guidance Document · Human Foods Program
• Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath MintsGuidance Document · Human Foods Program
• Guidance for Industry: Reference Amounts Customarily Consumed (List of Products for Each Product Category)Guidance Document · Human Foods Program
• Guidance for Industry: Proper Labeling of Honey and Honey ProductsGuidance Document · Human Foods Program
• E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)Guidance Document · Center for Drug Evaluation and Research
• Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)Guidance Document · Center for Drug Evaluation and Research
• Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Migraine: Developing Drugs for Acute TreatmentGuidance Document · Center for Drug Evaluation and Research
• Regulatory Classification of Pharmaceutical Co-CrystalsGuidance Document · Center for Drug Evaluation and Research
• How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for IndustryGuidance Document · Office of the Commissioner
• Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and PresentationGuidance Document · Center for Drug Evaluation and Research
• Small Entity Compliance Guide: Foreign Supplier Verification Programs for Importers of Food for Humans and AnimalsSmall Entity Compliance Guide · Human Foods Program
• Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507Guidance Document · Human Foods Program
• Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural CommoditiesGuidance Document · Human Foods Program
• Product Title and Initial US Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Material Threat Medical Countermeasure Priority Review Vouchers - Draft Guidance for Industry: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification ProgramsGuidance Document · Human Foods Program
• Labeling for Combined Hormonal Contraceptives Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Best Practices for Communication Between IND Sponsors and FDA During Drug DevelopmentGood Review Practices · Center for Drug Evaluation and Research
• Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Medical Device Accessories - Describing Accessories and Classification Pathways: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases: Guidance for IndustryGuidance Document · Office of the Commissioner
• Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review BoardsGuidance Document · Center for Devices and Radiological Health
• Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAsGuidance Document · Center for Drug Evaluation and Research
• Refuse to File: NDA and BLA Submissions to CDER Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-FinalGuidance Document · Center for Drug Evaluation and Research
• Software as a Medical Device (SAMD): Clinical Evaluation: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Technical Considerations for Additive Manufactured Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions: Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Small Entity Compliance Guide: Sanitary Transportation of Human and Animal Food - What You Need to Know About the FDA RegulationSmall Entity Compliance Guide · Human Foods Program
• General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Same Surgical Procedure Exception under 21 CFR 127115(b): Questions and Answers Regarding the Scope of the ExceptionGuidance Document · Center for Biologics Evaluation and Research
• Guidance for Industry: Use of the Terms “Brown King Crab” and “Golden King Crab” in the Labeling of Human Food ProductsGuidance Document · Human Foods Program
• Use of a Drug Master File for Shared System REMS Submissions Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Recurrent Herpes Labialis: Developing Drugs for Treatment and PreventionGuidance Document · Center for Drug Evaluation and Research
• Evaluating Drug Effects on the Ability to Operate a Motor VehicleGuidance Document · Center for Drug Evaluation and Research
• Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal FoodGuidance Document · Human Foods Program
• ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Recommendations for the Submission of LOINC® Codes in Regulatory Applications to the US Food and Drug Administration: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic ActGuidance Document · Human Foods Program
• Product Labeling for Certain Ultrasonic Surgical Aspirator Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507Guidance Document · Human Foods Program
• CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for AnimalsGuidance Document · Center for Veterinary Medicine
• Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Individual Patient Expanded Access Applications: Form FDA 3926Guidance Document · Center for Drug Evaluation and Research
• Waiver of IRB Requirements for Drug and Biological Product Studies: Guidance For Sponsors, Clinical Investigators, and IRBsInformation Sheet · Office of the Commissioner
• M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBsGuidance Document · Office of the Commissioner
• Q4B Annex 2: Test for Extractable Volume of Parenteral Preparations General ChapterGuidance Document · Center for Drug Evaluation and Research
• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Procedures for Meetings of the Medical Devices Advisory Committee: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Small Entity Compliance Guide: Mitigation Strategies to Protect Food Against Intentional AdulterationSmall Entity Compliance Guide · Human Foods Program
• CVM GFI #232 (VICH GL54) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)Guidance Document · Center for Veterinary Medicine
• CVM GFI #237 Oncology Drugs for Companion AnimalsGuidance Document · Center for Veterinary Medicine
• Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese ProductsGuidance Document · Human Foods Program
• Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial DiseasesGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food RuleGuidance Document · Human Foods Program
• Consumer Antiseptic Wash Final Rule Questions and Answers: Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
• PDEs for Triethylamine and for MethylisobutylketoneGuidance Document · Center for Drug Evaluation and Research
• M4E(R2): The CTD – EfficacyGuidance Document · Center for Drug Evaluation and Research
• Q3C Maintenance ProceduresGuidance Document · Center for Drug Evaluation and Research
• Current Good Manufacturing Practice for Medical Gases: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research