medicines-medical devices-regulatory affairs
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…
Date Title of guidance and link to document Type and levelof guidance About the guidance 29 Mar 2024 FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products Final The purpose of…
New guidance has been published on the MHRA website concerning process changes for the assessment of established medicines that come into effect on 1 March 2024. This post is an attempt to present the guidance information in a manner that…
Date Title of guidance and link to document Type and levelof guidance About the guidance 28 Dec 2023 Potency Assurance for Cellular and Gene Therapy Products Draft This draft guidance provides recommendations for developing a science- and risk-based strategy to…
Date Title of guidance and link to document Type and levelof guidance About the guidance 28 Sep 2023 Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding”OCTOBER 2023 Source: FDA…
Date Title of guidance and link to document Type and level of guidance About the guidance 27 Jun 2023 Prohibition on Wholesaling Under Section 503B of the FD&C ActSource: FDA Draft Under section 503B of the FD&C Act (21 U.S.C.353b),…