Zdrowie i gospodarka · 02/10/2024

FDA Releases Final Guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations

The US Food and Drug Administration (FDA) has released a final guidance document providing recommendations for the use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products, and new animal drugs, building on the trustworthiness and reliability of these electronic methods.