Guidances directory

All guidance documents2,828 total

• Withdrawn Guidances (Biologics)Guidance Document · Center for Biologics Evaluation and Research
• CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related ProductsGuidance Document · Center for Veterinary Medicine
• Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Approaches to Assessment of Overall Survival in Oncology Clinical Trials: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)Guidance Document · Center for Veterinary Medicine
• Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign GovernmentsGuidance Document · Center for Devices and Radiological Health
• E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling RecommendationsGuidance Document · Center for Drug Evaluation and Research
• Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Unique Device Identifier Requirements for Combination Products: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Conducting Remote Regulatory Assessments Questions and Answers: Guidance for IndustryGuidance Document · Office of Inspections and Investigations
• Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Post-Warning Letter Meetings Under GDUFAGuidance Document · Center for Drug Evaluation and Research
• ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug SubmissionsGuidance Document · Center for Drug Evaluation and Research
• Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• M11 Technical Specification: Clinical Electronic Structured Harmonised ProtocolGuidance Document · Center for Drug Evaluation and Research
• Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)Guidance Document · Center for Drug Evaluation and Research
• Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #287 - Raw Data for Safety and Effectiveness StudiesGuidance Document · Center for Veterinary Medicine
• M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Replacing Color Additives in Approved or Marketed Drug Products: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: - Final Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• FDA Inspections Operations Management Manual 2025Operations Manual · Office of Inspections and Investigations
• CHAPTER 48 - 7348809 Bioresearch MonitoringProgram · Office of Regulatory Affairs
• Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Data Standards CatalogGuidance Document · Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Human Foods Program Center for Veterinary Medicine
• Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical InvestigatorsInformation Sheet · Office of the Commissioner,Office of the Chief Medical Officer,Office of Clinical Policy
• Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBsGuidance Document · Office of the Commissioner
• Evaluation of Sex Differences in Clinical Investigations: Guidance for IndustryInformation Sheet · Office of the Commissioner
• Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in OncologyGuidance Document · Office of the Commissioner
• Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Developing Drugs for Optical ImagingGuidance Document · Center for Drug Evaluation and Research
• Considerations for Including Tissue Biopsies in Clinical TrialsGuidance Document · Office of the Commissioner
• Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is UnderwayGuidance Document · Office of the Commissioner
• Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #251 - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of DiseaseGuidance Document · Center for Veterinary Medicine
• CVM GFI #260 - Type VII Veterinary Master File for Research and Development and Risk ReviewsGuidance Document · Center for Veterinary Medicine
• CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval ProcessGuidance Document · Center for Veterinary Medicine
• Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested PartiesGuidance Document · Center for Drug Evaluation and Research
• Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Obesity and Overweight: Developing Drugs and Biological Products for Weight ReductionGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)Guidance Document · Human Foods Program
• Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination EventGuidance Document · Human Foods Program
• Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Considerations for Complying with 21 CFR 211110Guidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young ChildrenGuidance Document · Human Foods Program
• Validation and Verification of Analytical Testing Methods Used for Tobacco ProductsGuidance Document · Center for Tobacco Products
• Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived FoodsGuidance Document · Human Foods Program
• Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic ActGuidance Document · Human Foods Program
• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Advanced Manufacturing Technologies Designation ProgramGuidance Document · Center for Drug Evaluation and Research
• E6(R3) Good Clinical Practice: Annex 2Guidance Document · Center for Drug Evaluation and Research
• Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and DevicesGuidance Document · Center for Drug Evaluation and Research
• M15 General Principles for Model-Informed Drug DevelopmentGuidance Document · Center for Drug Evaluation and Research
• E11A Pediatric ExtrapolationGuidance Document · Center for Drug Evaluation and Research
• Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing DocumentGuidance Document · Office of the Commissioner
• Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH): Guidance for Industry Technical Specifications DocumentGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and ProductsGuidance Document · Office of the Commissioner
• Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Accelerated Approval – Expedited Program for Serious ConditionsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine MastitisGuidance Document · Center for Veterinary Medicine
• Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant FormulaGuidance Document · Human Foods Program
• Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy SubjectsGuidance Document · Center for Drug Evaluation and Research
• Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; AvailabilityGuidance Document · Office of the Commissioner
• Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic ProductsGuidance Document · Office of the Commissioner
• Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review OrganizationsGuidance Document · Center for Devices and Radiological Health
• Frequently Asked Questions — Developing Potential Cellular and Gene Therapy ProductsGuidance Document · Center for Biologics Evaluation and Research
• Nonclinical Safety Assessment of Oligonucleotide-Based TherapeuticsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: FDA's Voluntary Qualified Importer ProgramGuidance Document · Human Foods Program
• CPG Sec 540525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 710824)Compliance Policy Guide (CPG) · Human Foods Program
• M13A Bioequivalence for Immediate-Release Solid Oral Dosage FormsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed IngredientsGuidance Document · Center for Veterinary Medicine
• Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial ContaminationGuidance Document · Office of the Commissioner
• Drug Interaction Information in Human Prescription Drug and Biological Product LabelingGuidance Document · Center for Drug Evaluation and Research
• Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for IndustryGuidance Document · Office of the Commissioner
• Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat MethodGuidance Document · Center for Biologics Evaluation and Research