News Archive

EMA - Human Medicines Highlight Newsletter

20th September 2023

Edition 173

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

20th September 2023

Held 11-14 September 2023

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FDA - FDA Supports Innovation in Animal Biotechnology, Veterinary Products, Food for Animals Through New Comprehensive Agenda

20th September 2023

The FDA announced it is taking new steps to further modernise its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase regulatory flexibility, predictability and efficiency.

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FDA - Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products

20th September 2023

Guidance for IRBs and Clinical Investigators released September 2023

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FDA - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

20th September 2023

FDA releases guidance document

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FDA Roundup: 19th September 2023

20th September 2023

An at-a-glance summary of news from around the agency

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MHRA - How nurses can support patient safety through reporting adverse incidents

20th September 2023

Holly Coole, registered mental health nurse and senior manager for digital mental health at the MHRA, discusses how the safety of medical products is monitored and how all nurses can help ensure potential issues are picked up fast through the UK’s Yellow Card scheme.

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