medicines-medical devices-regulatory affairs
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…
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…
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…
Last updated: 7 February 2024 See updates at the end of the post. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of…
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and levelof guidance About the guidance 28 Dec 2023 Potency Assurance for Cellular and Gene Therapy Products Draft This draft guidance provides recommendations for developing a science- and risk-based strategy to…
Last updated: 6 December 2023 See updates at the end of the post. The FDA has partnered with Health Canada to launch a joint eSTAR pilot. What is eSTAR? Electronic Submission Template And Resource or eSTAR is an interactive PDF…
Last Updated: 1 November 2023 See updates at the end of the post. This post is an attempt to inform the reader about the FDA’s Knowledge-Aided Assessment and Structured Application (KASA) system. Please note that at the time of last…
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),…