Recently Issued Guidance Documents

Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA. Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry CDER/CBER, January 2026 Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER/CDER, January 2026 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, December 2025 Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry CDER/CBER, December 2025 Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry CDER/CBER/CDRH/OC, December 2025 Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices; Guidance for Industry CDER/CBER/CDRH/OCE, December 2025 Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products - Questions and Answers; Guidance for Industry CDER/CBER, December 2025 eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, December 2025 QTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry OCE/CDER/CBER, December 2025 Cross-Center Master Files: Where to Submit; Draft Guidance for Industry CDER/CBER/CDRH/CVM/OCP, November 2025 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry CDER/CBER, October 2025 Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, October 2025 Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry CDER/CBER/OCLiP/OCE, October 2025 Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders CDER/CBER/CDRH, October 2025 Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias; Guidance for Industry Technical Specifications Document OCE/CDER/CBER, October 2025 Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry CBER, September 2025 Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry CBER, September 2025 Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry CBER, September 2025 Computer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, September 2025 Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act; Draft Guidance for Industry CDER/CBER, September 2025 Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Guidance for Industry CDER/CBER, September 2025 Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Guidance for Industry CDER/CBER, September 2025 Classification Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER/CDER/OC, August 2025 Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry OCE/CDER/CBER, August 2025 Medical Device User Fee Small Business Qualification and Determination; Guidance for Industry and Food and Drug Administration Staff and Foreign Governments CDRH/CBER, July 2025 Medical Device User Fee Small Business Qualification and Determination; Guidance for Industry and Food and Drug Administration Staff and Foreign Governments CDRH/CBER, July 2025 Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products; Guidance for Industry CDER/CBER, July 2025 Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs' Effects; Draft Guidance for Industry OCE/CDER/CBER, July 2025 Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry CBER, July 2025