Recently Issued Guidance Documents

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. - Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, March 2026 - Pyrogen and Endotoxins Testing: Questions and Answers; Guidance for Industry CDER/CBER/CDRH/CVM/ORA, March 2026 - Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry CDER/CBER, March 2026 - Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection; Draft Guidance for Industry CDER/CBER/CVM/OII, March 2026 - Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry CBER/CDER, February 2026 - Computer Software Assurance for Production and Quality Management System Software; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, February 2026 - Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, February 2026 - Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval; Draft Guidance for Industry CDER/CBER/CDRH/OCE, January 2026 - Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry CDER/CBER, January 2026 - Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff CDRH/CBER/CDER, January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