2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
FDA Comment Number : EC4
Submitter : Ms. Orkideh Malkoc Date & Time: 10/10/2006 11:10:46
Organization : Genetic Alliance
Category : Association
Issue Areas/Comments
We understand, in the past, the public has made little to no comment on guidances. In order for the public to participate, we must have enough time to educate them on how to respond to guidances. Therefore, we ask that you extend the deadline by 90 days to make it possible to elicit the consumer communitys input in this process.