FDA Needs Radical Reform

The nomination of Dr. Scott Gottlieb for FDA commissioner, a political appointee, has created the usual bipartisan furor. He is called unqualified, a renegade, not committed enough to FDA orthodoxy, an industry darling by some and a maverick by others. All Continue reading FDA Needs Radical Reform

AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public.  The topic of the December 5th meeting:  Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1