News Archive

FDA - FDA Roundup: 16 June, 2023

20th June 2023

A roundup of FDA news

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FDA - Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry

20th June 2023

This guidance provides information to sponsors and nonclinical laboratories regarding the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical toxicology studies using non-human specimens.

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MHRA - Implementation of medical devices future regime

20th June 2023

The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.

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MHRA - New lay commissioner appointed to the Commission on Human Medicines

20th June 2023

Mr David Crundwell joined the Commission on Human Medicines on 12 June 2023 as a lay representative.

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WHO - Countries set out way forward for continued negotiations on global agreement on pandemic prevention, preparedness, and response

20th June 2023

Countries of the World Health Organization (WHO) have moved forward negotiations on a global accord on pandemic prevention, preparedness and response, with a view to presenting a draft accord to the World Health Assembly in May 2024.

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MHRA - MHRA issues new guidance on the use of life saving adrenaline auto-injectors

19th June 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidance includes an easy step-by-step guide on what to do in an emergency and provides updated advice on body positioning.

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EDQM - 2022 Highlights – EDQM annual report now available

14th June 2023

2022 Annual Report available to view

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EDQM - Ph. Eur. Commission keeps pace with veterinary vaccine development efforts

14th June 2023

Vaccines for veterinary use (0062), Evaluation of safety of veterinary vaccines and immunosera (5.2.6) and Evaluation of efficacy of veterinary vaccines and immunosera (5.2.7).

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EMA - CTIS Newsflash, June 2023

14th June 2023

CTIS newsflash – 9 June 2023

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EMA - Draft ICH E6 (R3) guideline on good clinical practice – step 2b

14th June 2023

The European Medicines Agency has published for public consultation a “Draft ICH E6 (R3) guideline on good clinical practice – step 2b”.

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