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Results: 1-10 of 84

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


The OIG applauds FDA’s progress in inspections of generic drug manufacturers but recommends more to be done
  • Arnall Golden Gregory LLP
  • 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


States seek to expand access to investigational drugs, biological products, and devices through “Right to Try” laws
  • Arnall Golden Gregory LLP
  • USA
  • June 24 2015

Since early 2014, at least forty states have introduced "Right to Try" laws, and twenty-two of those states have passed "Right to Try" laws. The goal


Off-label promotion, state-level injury lawsuits, and preemption
  • Arnall Golden Gregory LLP
  • USA
  • June 23 2015

The issue of preemption in product liability cases involving medical device products continues to evolve. Recently, the U.S. Court of Appeals for the


FDA and the FTC unfriend a dietary supplement product
  • Arnall Golden Gregory LLP
  • USA
  • May 27 2015

In an interesting Warning Letter recently issued, both the Food and Drug Administration and the Federal Trade Commission issued a Warning Letter to a


Break on through to the other side: an update on Breakthrough Therapy designation requests
  • Arnall Golden Gregory LLP
  • USA
  • May 27 2015

A recent public meeting on Breakthrough Therapy (BT) Designation after 2 years from implementation provided some interesting insight and trend


A funny thing happened on the way to the pharmacists meeting
  • Arnall Golden Gregory LLP
  • USA
  • May 26 2015

The Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued recently a Notice of Violation to a generic drug company


FDA and CMS announce joint task force on LDTs
  • Arnall Golden Gregory LLP
  • USA
  • April 22 2015

The U.S. Food and Drug Administration (FDA) recently announced the formation of an interagency task force with the Centers for Medicare and Medicaid


You look marvelous: just ask FDA whether beauty is in the eye of the beholder
  • Arnall Golden Gregory LLP
  • USA
  • April 21 2015

Many of us remember Billy Crystal's "You Look Marvelous" one-liner from "Saturday Night Live," where the comedic routine frequently ended with "It's


FDA shows displeasure with leasing 510(k)s
  • Arnall Golden Gregory LLP
  • USA
  • March 25 2015

Every week, we review a number of Warning Letters - fortunately, we review others companies' enforcement letters more than having to respond for our