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A Very Fine Line — Split Decision: FDA Issues Draft Guidance on Clinical Decision Support Software

USA - November 26 2019 From his 1986 “Back in the High Life” album, Steve Winwood sings, “It’s a fine line, a very fine line - split decision.” In fact, that’s what many…

Genevieve M. Razick.

Déjà Vu All Over Again: OPDP Sends Another Letter Regarding Website Promotion of an Investigational New Drug

USA - November 25 2019 On November 1, 2019, the Food and Drug Administration’s (FDA)Office of Prescription Drug Promotion (OPDP) sent an Untitled Letter to the sponsor of…

Seth S. Ray.

Medical Device Developments: FDA Finalizes Four 510(k) Guidance Documents

USA - October 29 2019 In September, the U.S. Food and Drug Administration issued multiple final guidance documents related to the medical device program. In this Bulletin…

Christine Kirk.

Another One Bites the Dust: FDA doesn’t like the fishy smell of the latest court decision on off-label dissemination

USA - August 19 2015 The Food and Drug Administration has lost yet another court decision challenging its ability to restrict a company's commercial free speech rights…

William H. Kitchens.

The OIG applauds FDA’s progress in inspections of generic drug manufacturers but recommends more to be done

USA - July 23 2015 The Department of Health and Human Services' Office of Inspector General has recently recommended that the Food and Drug Administration continue to…

Alexander B. Foster.