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• 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• Cross-Center Master Files: Where to Submit; Draft Guidance for Industry CDER/CBER/CDRH/CVM/OCP, November 2025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Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry CDER/CBER, October 2025
• Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, October 2025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• Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry CBER, September 2025
• Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry CBER, September 2025
• Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry CBER, September 2025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• Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act; Draft Guidance for Industry CDER/CBER, September 2025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 Categories for Certain Supplements Under BsUFA III; Guidance for Industry CDER/CBER, September 2025
• Marketing 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