FDA cites companies for CGMP violations, informed consent failure
<p>The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing to sufficiently inform subjects about the clinical trial they were participating in.</p>
21 Jul 2026 European Commission publishes guideline on transparency obligations under AI Act The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act, including examples of exceptions to these requirements. While not specific to healthcare products, companies developing healthcare products with an AI system component may be subject to transparency rules. Regulatory News
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