FDA Extensively Revises Clinical Trial Electronic Records Guidance

J.W. Schomisch
March 24, 2023 at 03:25 PM EST
After nearly six years, the FDA has extensively revised its draft guidance on the use of electronic systems, electronic records and electronic signatures in food, medical product, tobacco product and new animal drug clinical investigations. While the 2017 draft guidance dealt primarily with the use of electronic records and signatures in clinical trials for drugs and devices,... Read More

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