By Kurt R. Karst – Last Friday, FDA announced that the Agency licensed the fourth biosimilar biological product under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”): Amgen, Inc.’s (“Amgen’s”) AMJEVITA (adalimumab-atto) (BLA 761024), a biosimilar version of AbbVie Inc.’s (“AbbVie’s”) (BLA 125057) blockbuster …
By Alexander J. Varond – FDA’s rare pediatric disease priority review voucher program is set to expire on October 1. If this happens, FDA will no longer award pediatric vouchers to otherwise eligible sponsors. Expiration of the pediatric voucher program would mean the end (at least …
By Jennifer M. Thomas – As predicted in our last post on the significant Park-related litigation arising out of the Quality Egg case, Austin (Jack) and Peter Decoster timely petitioned for panel or en banc rehearing of their Eighth Circuit challenge to three-month prison sentences imposed …
By Dara Katcher Levy & Jenifer R. Stach – Ten years and two days after FDA issued the proposed rule, the Agency published the final rule – Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a …
By Ricardo Carvajal – FDA’s issuance of a draft guidance for industry titled Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling marks the first issuance of a guidance that addresses structure/function (SF) claim substantiation for a conventional food. As FDA explains in the guidance, …
By JP Ellison & Wes Siegner – There are 12 pages of FDA forms on the FDA website covering everything from product topics (foods, drugs, cosmetics, etc.) to safety forms and FDA field operations forms. Unless we missed it, one of FDA’s newest forms isn’t on its website. …
By Serra J. Schlanger & Alan M. Kirschenbaum – For 25 years, drug and device manufacturers and their customers have relied on the discount safe harbor under the Federal health care program antikickback statute (“AKS”) to protect procompetitive discount arrangements that save money for purchasers, patients, …
By Allyson B. Mullen – As our blog readers know, the 510(k) Third Party Review Program has been a bit of a flop in terms of utilization and clearance times (see our previous post here). In Fiscal Years 2013, 2014, and 2015, only 3.2%, 2.2%, and 2.3% …
By Kurt R. Karst – What a difference a few precedents can make! In a rather surprising turn of events, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia issued a Memorandum Opinion last Friday granting a Motion for Reconsideration filed by …
By Riëtte van Laack – Last week, FDA announced its final rule regarding over-the-counter (OTC) consumer antiseptic wash products. As we reported in 2013, FDA issued a proposal to declare all antimicrobial consumer hand wash products as not generally recognized as safe and effective but invited comments …
By John A. Gilbert, Jr. & Larry K. Houck – This is third in a series of in-depth reviews of the Drug Enforcement Administration’s (“DEA’s”) and other federal agencies’ recent decisions/notices on marijuana and industrial hemp issued on August 12, 2016. Previously, we reviewed DEA’s policy …
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 …
