FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelines

The U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements.

One firm was also cited for failing to provide sufficient information to participants about the clinical trial they were enrolled in.

The European Commission meanwhile published new guidelines to help AI system providers meet transparency obligations under the EU AI Act, a move that could impact developers of healthcare products that incorporate artificial intelligence.