Guidances directory

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All guidance documents2,854 total

Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
FDA Records Access Authority for Cosmetic Products: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: QualityGuidance Document · Center for Drug Evaluation and Research
Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for IndustryGuidance Document · Office of Inspections and Investigations
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
Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for IndustryGuidance Document · Office of Inspections and Investigations
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Study of Sex Differences in the Clinical Evaluation of Medical ProductsGuidance Document · Center for Drug Evaluation and Research
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for IndustryGuidance Document · Office of the Commissioner
eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable MonographsGuidance Document · Center for Drug Evaluation and Research
Medical Gases — Current Good Manufacturing Practice: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Q3E Guideline for Extractables and LeachablesGuidance Document · Center for Drug Evaluation and Research
Cross-Center Master Files: Where to Submit: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for IndustryGuidance 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
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome AssessmentsGuidance Document · Center for Drug Evaluation and Research
Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias: Guidance for Industry Technical Specifications DocumentGuidance Document · Office of the Commissioner
CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication: Guidance for IndustryGuidance Document · Center for Veterinary Medicine
E20 Adaptive Designs for Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Malaria: Developing Drugs for Treatment: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Erosive Esophagitis: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
Disseminated Coccidioidomycosis: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending ApplicationsGuidance 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
E6(R3) Good Clinical Practice (GCP)Guidance Document · Center for Drug Evaluation and Research
Classification Categories for Certain Supplements Under BsUFA IIIGuidance Document · Center for Drug Evaluation and Research
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
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