medicines-medical devices-regulatory affairs
Date Title of guidance and link to document Type and level of guidance About the guidance 31 Mar 2023 Identification of Medicinal Products — Implementation and Use Source: FDA Final This guidance is for sponsors, applicants, and registrants who are…
Last updated: 28 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 24-26 January 2023 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 27 February 2023 See updates at the end of the post. EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 Revision 1 of the above document dated 15 Feb…
Last updated: 11 May 2023 See updates at the end of the post. In December 2022, I wrote a blog post on the chatbot, ChatGPT. So much has happened since then. There has been an explosion of articles and video…
Date Guidance No About the guidance 14 Feb 2023 MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices – February 2023 This document aims to clarify important terms…
Last updated: 6 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 13-14 December 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
In 2021, the MHRA held a public consultation seeking views on a legislative proposal to introduce a new regulatory framework for the manufacture and supply of Point of Care (POC) products. This post is about the formal government response to that consultation.…
This post is an attempt to provide a snapshot of the multidistrict litigation (MDL) in the US concerning ranitidine, marketed under the name of Zantac. Most of the information for this post comes from the 341 page ruling1 of December…
Last updated: 27 January 2023 See update(s) at the end of the post. This post is an attempt to provide basic information on CAR-T cell therapy. The information is by no means exhaustive and can be used a starting point…
Title of guidance Type and level of guidance About the guidance Source E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers Final guidance The ICH E2C(R2) IWG has prepared this Q&A document to support implementation of the guidance in practice.…
Last updated: 20 December 2022 See updates at the end of this post. Report and minutes from the CMDh meeting held on 8-10 November 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Health Canada is consulting on proposed Agile regulations and guidance for licensing drugs and medical devices. It is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These changes will continue to…