By Kurt R. Karst – Our hopes that FDA might publish a proposed rule to implement at least some of the changes made to the Hatch-Waxman Amendments to the FDC Act by the Medicare Modernization Act (“MMA”), enacted on December 8, 2003, before the 10-year anniversary …
By Kurt R. Karst – A Complaint recently filed in the U.S. District Court for the District of Delaware by Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) against Par Pharmaceutical, Inc. (“Par”) concerning notice of a Paragraph IV certification contained in an ANDA Par submitted to FDA for …
By Kurt R. Karst – Earlier this week, Representative Robert Hurt (R-VA) introduced new legislation – H.R. 3631, the Small Manufacturer Protection Act of 2013 – that, if enacted, would bring relief to some companies that are required to pay user fees under the Generic Drug …
By Douglas B. Farquhar – Well, that certainly didn’t take long. FDA has clearly been eager to initiate its new, clarified powers over compounding pharmacies. President Obama only signed the new act (the Drug Quality and Security Act) the day before Thanksgiving, and this morning we find …
By Kurt R. Karst – The number of citizen petitions pending at FDA concerning Hatch-Waxman exclusivity continues to pile up. As we previously reported (here and here), FDA has already been asked on three separate occasions in 2013 to recognize 5-year New Chemical Entity (“NCE”) exclusivity …
By Kurt R. Karst – “Oddities” are not the sole domain of the world of antiques and other rarities (for those of you who are fans of the television show that focuses on the day-to-day operation of Obscura Antiques & Oddities). Food and drug law – …
By Kurt R. Karst – In what appears to be the first dismissal (Docket No. FDA-2012-E-0491) of a Patent Term Extension (“PTE”) application in what has been referred to as a “reverse Photocure” scenario, the Patent and Trademark Office (“PTO”) has determined that U.S. Patent No. …
By Karla L. Palmer – As reported here yesterday on the track and trace provisions, after many months of legislative maneuvering and various iterations emanating from both the House and Senate, the Senate passed without amendment and by voice vote H.R. 3204 – the “Drug Quality …
By Jessica A. Ritsick & William T. Koustas – Over 25 years ago, the Prescription Drug Marketing Act ("PDMA") was passed. The PDMA called for implementation of a national system to follow prescription drugs through the supply chain. After years of talking about it (see here), …
By Jessica A. Ritsick & William T. Koustas – At this year’s Health Care Distribution Management Association (HDMA) annual track-and-trace conference, most minds were focused on one thing: the potential passage of H.R. 3204, the Drug Quality and Security Act, which would mandate a uniform, national, interoperable electronic …
By Jennifer M. Thomas – The generic drug industry has waited with bated breath since, as we reported here and here, FDA signaled that it was “considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.” See …
An article published in the current edition of Regulatory Focus, the flagship publication of the Regulatory Affairs Professionals Society (RAPS), and authored by Hyman, Phelps & McNamara, P.C.’s Alexander J. Varond discusses the recent trends and developments in personalized medicine, including FDA’s current thinking and …
By Jennifer M. Thomas – I have monitored the drug shortage issue over the last few years with professional interest and general concern (see here). However, the situation was recently brought home to me when I took my four-month old in for her second round of …
By Kurt R. Karst – The forces backing implementation of an FDA policy under which biosimilar biological products, licensed under Section 351(k) of the Public Health Service Act (“PHS Act”) as added by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and their …
By Kurt R. Karst – The Generic Pharmaceutical Association (“GPhA”) held its annual Fall Technical Conference this week. There were lots of interesting topics on the conference agenda, such as complex drugs, ANDA filing and refuse-to-receive issues (see the recent FDA guidance here), adverse event …
