Recently Issued Guidance Documents
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- 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OCE/CDER/CBER, October 2025 - Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry
CBER, September 2025 - Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry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September 2025 - Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry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CDRH/CBER, September 2025 - Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act; Draft Guidance for Industry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CDRH/CBER/CDER/OC, August 2025 - Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry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 - Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment; Draft Guidance for Industry
OCE/CDER/CBER/CDRH, July 2025 - Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry
OCP/CBER/CDER/CDRH, June 2025 - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, June 2025 - Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, June 2025 - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, May 2025 - Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, May 2025 - 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 Industry
CBER, May 2025