FDA Issues Advanced Notice of New GLP Rules for Non-clinical Studies
This post was written by Paul Sheives.
Following a workgroup’s conclusion that non-clinical studies should be conducted under a good laboratory practices (GLPs) quality system approach, FDA has decided to modify the existing GLP regulations for non-clinical studies. FDA seeks comments regarding potential changes to regulations addressing: (1) multi-site studies; (2) electronic automation systems; (3) sponsor responsibilities; (4) animal welfare; (5) information on quality assurance inspectional findings; (6) process-based systems; (7) test and control article information; and (8) sample storage container retention. In addition, FDA is considering whether to include in the regulations a core set of essential elements for such a GLP quality system. FDA is accepting written comments until February 22, 2011.
