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Industry news

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FDA releases new draft guidance on assessing artificial intelligence data

2025-01-17T16:24:00+00:00By

The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.

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ICH releases M15 Guideline on Model-informed Drug Development

2025-01-16T16:56:00+00:00By

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M15 Expert Working Group has developed a draft guideline on model-informed drug development (MIDD) and is now under public consultation. 

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EC announces evaluation of medical device and IVD regulations

2025-01-09T16:47:00+00:00By

The European Commission (EC) has announced an evaluation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

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Use of new EMA platform for monitoring medicine shortages to become mandatory

2024-12-13T11:17:00+00:00By

The European Medicines Agency (EMA) has launched the European Shortages Monitoring Platform (ESMP), aimed at preventing and managing shortages of centrally authorised products (CAPs).