Guidances directory

All guidance documents2,828 total

• Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid ActivityGuidance Document · Center for Drug Evaluation and Research
• Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome Instrument for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory UseGuidance Document · Center for Drug Evaluation and Research
• Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Small Entity Compliance Guide: Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Nutrient Content ClaimsSmall Entity Compliance Guide · Human Foods Program
• Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical InvestigationsGuidance Document · Center for Drug Evaluation and Research
• Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• List of Highest Priority Devices for Human Factors Review: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #226 Target Animal Safety Data Presentation and Statistical AnalysisGuidance Document · Center for Veterinary Medicine
• Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for use in Companion AnimalsGuidance Document · Center for Veterinary Medicine
• Certification Process of Designated Medical GasesGuidance Document · Center for Drug Evaluation and Research
• Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use —: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants: Guidance for IndustryGuidance Document · U.S. Department of Health and Human Services
• Qualification of Biomarker — Galactomannan in studies of treatments of invasiveGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Questions and Answers on FDA’s Fortification PolicyGuidance Document · Human Foods Program
• DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate RouteGuidance Document · Center for Drug Evaluation and Research
• National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions – Small Entity Compliance Guide: Guidance for IndustrySmall Entity Compliance Guide · Center for Tobacco Products
• CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E coli in CattleGuidance Document · Center for Veterinary Medicine
• Integrated Summary of EffectivenessGuidance Document · Center for Drug Evaluation and Research
• Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Product Development Under the Animal RuleGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 100101 Crotalaria spp Seeds in GrainsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent: Guidance for Industry and Tobacco RetailersGuidance Document · Center for Tobacco Products
• Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Nonclinical Evaluation of Endocrine-Related Drug ToxicityGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Colored Sea SaltGuidance Document · Human Foods Program
• CVM GFI #225 (VICH GL53) Electronic Exchange of Documents: File Format RecommendationsGuidance Document · Center for Veterinary Medicine
• Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Uncomplicated Gonorrhea: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic DevicesGuidance Document · Center for Devices and Radiological Health
• Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription DrugsGuidance Document · Center for Drug Evaluation and Research
• Over-the-Counter Pediatric Oral Liquid Drug Products Containing AcetaminophenGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #220 Use of Nanomaterials in Food for AnimalsGuidance Document · Center for Veterinary Medicine
• Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• CVM GFI #198 (VICH GL45) Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal ProductsGuidance Document · Center for Veterinary Medicine
• Analytical Procedures and Methods Validation for Drugs and BiologicsGuidance Document · Center for Drug Evaluation and Research
• Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration StaffGuidance Document · Office of the Commissioner
• Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and TransportationGuidance Document · Human Foods Program
• Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Food Allergen Labeling Exemption Petitions and NotificationsGuidance Document · Human Foods Program
• Naming of Drug Products Containing Salt Drug SubstancesGuidance Document · Center for Drug Evaluation and Research
• Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #218 Cell-Based Products for Animal UseGuidance Document · Center for Veterinary Medicine
• CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive PetitionsGuidance Document · Center for Veterinary Medicine
• Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide)Small Entity Compliance Guide · Center for Drug Evaluation and Research
• Investigational New Drug Applications Prepared and Submitted by Sponsor-InvestigatorsGuidance Document · Center for Drug Evaluation and Research
• Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Scientific Considerations in Demonstrating Biosimilarity to a Reference ProductGuidance Document · Center for Drug Evaluation and Research
• Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and BiologicsGuidance Document · Center for Drug Evaluation and Research
• Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #211 Residual Solvents in Animal Drug Products Questions and AnswersGuidance Document · Center for Veterinary Medicine
• Abuse-Deterrent Opioids-Evaluation and LabelingGuidance Document · Center for Drug Evaluation and Research
• Critical Path Innovation MeetingsCenter for Drug Evaluation and Research
• Electronic Submission of Lot Distribution Reports: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Small Entity Compliance Guide: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food EstablishmentsGuidance Document · Human Foods Program
• CVM GFI #208 (VICH GL49) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion StudiesGuidance Document · Center for Veterinary Medicine
• CVM GFI #207 (VICH GL48) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs In Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal PeriodsGuidance Document · Center for Veterinary Medicine
• Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Alcoholism: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• S10 Photosafety Evaluation of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• DSCSA Implementation: Product Tracing Requirements — Compliance PolicyGuidance Document · Center for Drug Evaluation and Research
• Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 540275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coliCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance Document · Center for Drug Evaluation and Research
• DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics ProvidersGuidance Document · Center for Drug Evaluation and Research
• Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• SUPAC: Manufacturing Equipment AddendumGuidance Document · Center for Drug Evaluation and Research
• Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture: Final GuidanceGuidance Document · Center for Biologics Evaluation and Research
• CPG Sec 540700 Labeling of Processed and Blended Seafood Products Made Primarily with Fish ProteinCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Vaginal Microbicides:Development for the Prevention of HIV Infection PDFGuidance Document · Center for Drug Evaluation and Research
• Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Specification of the Unique Facility Identifier (UFI) System for Drug EstablishmentGuidance Document · Center for Drug Evaluation and Research
• New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #143 (VICH GL30) Pharmacovigilance of Veterinary Medicinal Products: Controlled List of TermsGuidance Document · Center for Veterinary Medicine
• New/Revised/Withdrawn Guidances 2014Guidance Document · Center for Drug Evaluation and Research
• CVM GFI #224 (Supplement to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Guidance GL52Guidance Document · Center for Veterinary Medicine
• Custom Device Exemption: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Unique Device Identifier System: Frequently Asked Questions, Vol 1 : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Immunogenicity Assessment for Therapeutic Protein ProductsGuidance Document · Center for Drug Evaluation and Research
• Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration StaffSmall Entity Compliance Guide · Center for Devices and Radiological Health