By Kurt R. Karst – Back in September 2013, when FDA’s Office of Generic Drugs (“OGD”) was gearing up for significant implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) (and the associated Performance Goals and Procedures), the Office issued a Manual of Policies …
By Kurt R. Karst – It seems that hardly a week passes (and sometimes, hardly a day or two) without news of a new merger or acquisition in the pharmaceutical or biotechnology industries. Indeed, 2015 may be a record-breaking year for such deals (see here, here, …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Maryland unsealed a 73-page Opinion handed down on July 29, 2015, along with an Order, in a challenge brought by Mallinckrodt Inc. (“Mallinckrodt”) last November after FDA downgraded from “AB” …
By Kurt R. Karst – There are few things this blogger relishes more in his practice than getting his hands on FDA exclusivity decisions. (It’s like being given and then unwrapping a holiday gift.) We don’t mean the “decisions” that most people see in ANDA approval letters …
By Kurt R. Karst – It’s been almost seven weeks since the U.S. District Court for the District of Columbia issued its Opinion in Veloxis Pharmaceuticals. Inc. v. FDA, ___ F.Supp.3d ___, 2015 WL 3750672 (June 12, 2015), a challenge concerning the scope of 3-year new …
By Kurt R. Karst – A “phantom” is defined, in part, to mean “an appearance or illusion without material substance, as a dream image, mirage, or optical illusion.” That’s probably the best way to sum up what’s at the heart of the issues raised by FDA …
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
By Kurt R. Karst – As the years go by and nostalgia creeps in, we reminisce about the past and how things were “back then” (which to this blogger means the 1980s and 1990s). It’s not that things were necessarily better “back then,” they were just …
By Kurt R. Karst – One of the more memorable lines from the original Star Wars Trilogy is uttered in Return of the Jedi when Luke Skywalker surrenders himself to Darth Vader on the Forest Moon of Endor. Luke tries to convince Vader to return to …
The American Conference Institute (“ACI”) will hold its 26th FDA Boot Camp conference in Boston, Massachusetts from September 30 to October 1, 2015. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will co-chair the event with …
By Kurt R. Karst – We try our best to stay on top of the latest lawsuits against FDA, but every once in a while one gets past us without us quickly noticing. That recently happened when Prometheus Laboratories Inc. (“Prometheus”) filed a Complaint and a …
By Kurt R. Karst – For months now we’ve been waiting patiently for anything out of the U.S. District Court for the District of Columbia with respect to the case that Veloxis Pharmaceuticals, Inc. (“Veloxis”) initially lodged against FDA in December 2014 (and then re-upped in …
By Kurt R. Karst – The folks over at Inside Health Policy brought to our attention a recent article authored by Len M. Nichols, Ph.D., Director and Professor of Health Policy at the George Mason University Center for Health Policy Research & Ethics that we thought …
By Kurt R. Karst – Sometimes curiosity gets the better of us . . . . We take some bait and go down a rabbit hole. That’s what happened last week after FDA published a notice in the Federal Register announcing the Agency’s determination that Ondansetron …
By Kurt R. Karst – We thought FDA would be hauled into court after the Agency denied, on October 10, 2014, two Petitions for Reconsideration (here and here) asking the Agency to rethink a February 21, 2014 Consolidated Response Denial to three Citizen Petitions requesting that …
