Extended comment period for IVDMIA guidance

Stakeholders have until Oct. 17 to submit additional comments on FDA's draft guidance on in vitro diagnostic multivariate index assays. A 30-day comment period on the agency's revised draft, which would assert FDA enforcement over certain lab-developed tests, initially closed Aug. 27, but critics said there had been insufficient time to thoroughly evaluate the guidance's implications (1"The Gray Sheet" Sept. 3, 2007, p. 7)