medicines-medical devices-regulatory affairs
Last updated: 20 March 2023 See updates at the end of this post. Since the end of November 2022, the internet has been abuzz with news about a chatbot called ChatGPT (which is a Generative AI). Many of you will…
Last updated: 4 April 2023 See updates at the end of the post. Q&A about the raw data proof-of concept pilot for industry In July 2022, the EMA launched a pilot project to assess whether the analysis of ‘raw data’…
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…
Between Between August and December 2022, Swissmedic launched a focus campaign to investigate how the new regulation was being implemented with regard to Class I Medical devices. It reviewed declarations of conformity, evidence that Swissmedic had been notified of the…
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…
On 6 January 2023, the European Commission adopted a proposal allowing more time to certify medical devices to mitigate the risk of shortages. The proposal: Further details are provided below. What does the length of the proposed extension period depend…