By Wes Siegner – After 20 years of marketing vinpocetine, and accepting without objection the filing of 5 new dietary ingredient notifications (NDINs), FDA has “tentatively concluded” that vinpocetine is an illegal dietary ingredient for two reasons: 1) it does not fit within the statutory list …
By Kurt R. Karst – Last week, Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”), a hedge fund with investment interests in Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda’s”) gout flare drug COLCRYS (colchicine) Tablets, 0.6 mg (NDA 022352), filed a Petition for Rehearing …
The American Conference Institute’s (“ACI’s”) Food Law Regulation Boot Camp is slated to take place at the InterContinental Chicago Magnificent Mile in Chicago, Illinois from November 15-16, 2016. The conference is billed as a way to “[c]onnect the dots of food regulatory law and gain …
Over the course of roughly the last year, gene editing has gone from being a topic limited to scientific conferences to being featured in the New York Times and on the cover of TIME magazine. Most of the attention has been due to a molecular …
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. Furthermore, increased enforcement aimed at the medical …
By Anne K. Walsh & Andrew J. Hull – FDA announced in an August 31, 2016 notification (“Notification”) that it will convene a public hearing to address its authority to regulate communications regarding unapproved uses of approved or cleared drugs and medical devices. The public hearing …
