Join the discussion -- RAPS Regulatory Exchange

RE:U.S. Regional information in DSUR
Posted: 5/18/2013 4:30:58 PM
From : Discussion Post>>Regulatory Open Forum
Suzanne, That is a regional requirement in the US pursuant to 21 CFR 312.33(e). (e) A description of any significant Phase 1 protocol modifications made during the previous year and not previously reported to the IND in a protocol amend...

U.S. Regional information in DSUR
Posted: 5/18/2013 2:53:58 PM
From : Discussion Post>>Regulatory Open Forum
Just wondering why there's a specific section for significant phase I protocol modifications made during the reporting period that have not been submitted as a protocol amendment. Surely all significant protocol modifications regardless of ph...

RE:FDA CFR Part 11
Posted: 5/17/2013 9:40:05 PM
From : Discussion Post>>Regulatory Open Forum
It is not an electronic record if you are printing the page and attaching it to the spreadsheet. Your spreadsheet is not subject to 21 CFR Part 11 (Electronic Signatures/Electronic Records). 21 CFR Part 111 (cGMP for Dietary Supplements) d...