medicines-medical devices-regulatory affairs
Date Title of guidance and link to document Type and levelof guidance About the guidance 29 Oct 2025 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Further reading:1) FDA relaxes…
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…
On 3 September 2025, FDA’s CDER and CBER proposed a new process under Rare Disease Evidence Principles (RDEP) to facilitate the approval of drugs to treat rare diseases with very small patient populations with significant unmet medical need and 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…
Last updated: 6 November 2024 To see updates, click on the ‘+’ sign below. FDA is establishing the Split Real Time Application Review (STAR) pilot program under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. This post is…
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…
Last updated: 26 March 2025 To see updates, click the’+’ sign below: This post is an attempt to provide some basic information on Project Orbis, an FDA initiative to facilitate faster access to innovative cancer therapies. An important limitation in…
On January 31, 2024, the FDA issued a final rule (Medical Devices; Quality System Regulation Amendments) which was published on 2 February 2024 and will become effective on 2 February 2026. Why was the final rule issued? The final rule was issued…