News & Analysis as of

Digital Health Risk Management Corporate Counsel

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - August 5th, Philadelphia, PA

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

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