By Kurt R. Karst – Last Friday morning (October 10th) something interesting popped up out of the blue on FDA’s “What’s New Related to Drugs” webpage: the final version of FDA’s “Guidance for Industry – New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.” But …
By Kurt R. Karst – Colchicine is one of those drugs that has a long and storied history at FDA. It’s an old drug (about 200 years old) that was marketed for decades without FDA approval. Then, in 2009, FDA approved Mutual Pharmaceutical Company, Inc.’s (and …
By Kurt R. Karst – As most folks know by now, earlier this month the President’s Council of Advisors on Science and Technology (“PCAST”) released a report to the President titled “Combating Antibiotic Resistant Bacteria.” The report is part of a broader initiative announced by The …
By Kurt R. Karst – Thanks to everyone who participated in our “30 for 30” Hatch-Waxman Trivia! Based on the corrrespondence we received since posting the trivia questions earlier this week, FDA Law Blog readers enjoyed the trip down memory lane. . . and were entertained along the …
By Kurt R. Karst – It’s difficult to believe that almost 30 years have passed since President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984 on September 24, 1984. So much in Hatch-Waxman law (or Waxman-Hatch law if …
By Kurt R. Karst – There have been rumors floating around Washington, DC for a few months that efforts were afoot to introduce legislation to amend the FDC Act to address the availability of products subject to a restricted distribution program to generic drug and biosimilar …
By Kurt R. Karst – There are mortal sins and there are venial sins. In the latest guidance documents FDA announced (here and here) earlier this week – a final guidance on ANDA Refuse-to-Receive (“RTR”) standards and a draft guidance on ANDA RTR for lack of …
By Kurt R. Karst – In the 2003 movie “Freaky Friday,” based on the novel of the same name by Mary Rodgers, teenager Anna Coleman (played by Lindsay Lohan) and her mother, Tess Coleman (played by Jamie Lee Curtis), have their souls switched due to an …
By Kurt R. Karst – Last week, Connecticut Attorney General George Jepsen announced the submission of extensive comments to FDA that press the Agency to “exercise its discretion to immediately waive the 180-day waiting period and approve the sale” of generic versions of AstraZeneca LP’s NEXIUM …
By Kurt R. Karst – It was just a few months ago that we posted on what might have been the first decision in a case involving a counterclaim seeking an order to correct or delete patent information from the Orange Book (and that does not …
By Kurt R. Karst – With the recent litigation surrounding FDA’s approval of ANDAs for generic versions of PRECEDEX (dexmedetomidine HCl) Injection – which litigation has now moved on to Motions for Summary Judgment (see our updates here for the latest briefs) – we’ve had renewed …
By Kurt R. Karst – The hope is that years from now (but hopefully not too many years), once the review and performance metrics FDA agreed to as part of the Generic Drug User Fee Amendments are in full effect and 10-month ANDA reviews (resulting in …
By Kurt R. Karst – This blogger’s oldest child started middle school this past week. Naturally, I was excited to get his impressions of the first day of school. “Good” was his initial comment – a now all too familiar one-word tween response with which I …
By Alan M. Kirschenbaum – Beginning with CY 2011, Section 9008 of the Patient Protection and Affordable Care Act (“ACA”) has imposed an annual fee on manufacturers and importers of “branded prescription drugs.” The global 2014 fee for all manufacturers and importers is $3 billion, to …
By Kurt R. Karst – The pace of litigation concerning FDA’s approval of generic versions of Hospira, Inc.’s (“Hospira’s”) PRECEDEX (dexmedetomidine HCl) Injection, 100 mcg (base)/mL packaged in 200 mcg(base)/2 mL single-dose vials, has been anything but sedate. On the morning of August 18, 2014, there …
