medicines-medical devices-regulatory affairs
You can listen to available guidance podcasts at this link. Date Title of guidance and link to document Type and levelof guidance About the guidance 12 Aug 2026 Container Closure Systems for Human Drugs and Biological Products Draft, Level 1…
You can listen to available guidance podcasts at this link. Date Title of guidance and link to document Type and levelof guidance About the guidance 25 Jun 2026 Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level…
Date Title of guidance and link to document Type and levelof guidance About the guidance 27 Mar 2026 Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle Final This guidance provides recommendations on how voluntary “patient preferenceinformation” (PPI)…
Date Title of guidance and link to document Type and levelof guidance About the guidance 17 Dec 2025 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Medical Devices) Further reading:FDA finalizes real-world evidence guidance for device sponsors,…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Sep 2025 E20 Adaptive Designs for Clinical Trials Draft, Level 1 This document provides guidance on confirmatory clinical trials with an adaptive design intended…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Jun 2025 (Medical Devices) Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Final This guidance is applicable to devices with…
Date Title of guidance and link to document Type and levelof guidance About the guidance 5 Feb 2025 Institutional Review Boards Frequently Asked Questions Final This a compilation of answers to questions asked of FDA regarding the protection of human…
Date Title of guidance and link to document Type and levelof guidance About the guidance 31 Dec 2024 Advanced Manufacturing Technologies Designation Program Final, Level 1 This guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced…
Date Title of guidance and link to document Type and levelof guidance About the guidance 25 Sep 2024 Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Final This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Jun 2024 Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Draft This guidance is intended to assist sponsors…