medicines-medical devices-regulatory affairs
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…
Last updated on 26 September 2023 See updates at the end of the post. Guidance for the transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation The European Commission recently published guidance on the transition…
Last updated: 25 July 2024 See updates at the end of the post. This post is an attempt to facilitate an understanding of some of the complexities associated with the affixing of proprietary trademarks to repackaged generic medicinal products, for…
The table below details the Timeline of proposed changes to the regulatory framework for clinical trials in the UK. Date(s) Event Notes 17 Jan -14 Mar 2022 MHRA public consultation on proposals for legislative changes for clinical trials. This consultation…
Last updated: 27 July 2023 See updates at the end of the post. Draft Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle This reflection paper provides considerations on the use of AI and Machine…
Last updated: 20 December 2023 See updates at the end of the post. Chatbots have finally come of age and are here to stay. On 21 March 2023, Google launched Bard. The launch of ChatGPT late last year created a…
Last updated: 13 July 2024 To see updates, click on the ‘+’ sign below On 20 March 2023, Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs was published.…
Date Guidance No About the guidance 30 Jun 2023 Add 1 – MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate Addendum…
Last updated: 28 June 2023 See updates at the end of the post. Procedural advice on publication of information on withdrawals of applications for marketing authorisation and variations/extensions to marketing authorisations Revision 2 (of 27 June 2023) of the above…
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),…
Combination products are medicinal products with a medical device component. Combination products can either be non-separable combinations or separable combinations. EU MDR amendment of 20 March 2023 Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional…
Last updated: 2 June 2023 See updates at the end of the post. “Blue – Box” requirements “Blue – Box” requirements concern additional information on labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of…