FDA seeks input on new draft guidance covering next-generation sequencing tests
WASHINGTON Next-generation sequencing-based tests are taking center stage on Friday, with the FDA seeking the public's feedback on two draft guidance documents intended to support President Barack Obama's Precision Medicine Initiative.
Device flight round trips, and other matters
Never a dull moment in the world of medical devices and the Food and Drug Administration, is there? Sometimes the FDA is on the march, other times it seems the agency is about to be eclipsed by other forces. Don't be fooled by the picture on the left, though. There is no FDA airline, or any intent by the agency to regulate airlines (none that we know of, anyway) other than the food they serve on board. (MDD Perspectives)
Alere, Abbott agree to mediation, not much else in contested merger nuptials
A court battle between Alere Inc. and its potential acquirer Abbott Labs could be inching towards a resolution. The two sides agreed last week to work with a mediator to resolve the dispute, which has landed in the Delaware Chancery Court.