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 | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
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. | ||||||||||||||||||||||||