FDA Seeks Comment On Draft Guidance On Securing Clinical Trial Data

FDA has issued draft guidance that updates requirements for the handling of electronic records and data used in reviewing drugs and medical devices as part of clinical trials. The draft guidance , “Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11-- Questions and Answers,” updates procedures set in 2003 in an effort to expand the use of electronic medical records. FDA will accept comments for the next 60 days. “The guidance discusses the procedures...