By Kurt R. Karst – Like any good thriller movie that coaxes you into a feeling of finality – right before the surprise twist makes you jump out of your seat – the saga over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 …
By Kurt R. Karst – On October 19, 2011, FDA issued a proposed rule to amend the Agency’s December 29, 1992 (57 Fed. Reg. 62,076) orphan drug regulations. The proposal is not a whole-scale overhaul of FDA’s orphan drug regulations, but rather a group of amendments …
By William T. Koustas – We have previously reported (here, here, here, and here) on the court struggle in the United States District Court for the District of Columbia (“the Court”) between FDA and Regenerative Sciences, Inc. (“Regenerative”). Regenerative challenges FDA’s claim that the company’s stem …
By Kurt R. Karst – A Standard Operating Procedures and Policies (“SOPP”) prepared and used by FDA’s Office of Orphan Products Development (“OOPD”) for the review of orphan drug designation requests was recently made public and provides some interesting (and helpful) insight into OOPD’s policies. Of particular …
By Kurt R. Karst – “That’s all I can stand, I can’t stands no more.” Those were the words spouted by Popeye the Sailor at the climax of each cartoon episode after having been threatened with bad behavior from an antagonist like Bluto or the Sea …
By Kurt R. Karst – The first U.S. Conference on Rare Diseases and Orphan Products started with a bang today with the release of a landmark report announcing its findings of flexibility in FDA’s review of potential treatments for patients with rare (“orphan”) diseases. The conference, …
By Kurt R. Karst – Since we last updated our popular Generic Drug Labeling Carve-Out Citizen Petition Scorecard in February 2011, there have been several new citizen petitions submitted to FDA raising questions about FDA approval of ANDAs with labeling that omits information protected by periods …
By Kurt R. Karst – Last week, Representative Michael McCaul (R-TX), along with Reps. G.K. Butterfield (D-NC), Sue Myrick (R-NC), and Chris Van Hollen (D-MD), introduced H.R. 3059, the Creating Hope Act of 2011. The bill is a companion bill to S. 606, which was introduced …
By Kurt R. Karst – A recent decision from the U.S. District Court for the Eastern District of North Carolina in patent infringement litigation concerning Sandoz, Inc.’s (“Sandoz’s”) pending ANDA for a generic version of XYZAL (levocetirizine dihydrochloride) is one of the rare instances in which …
By Michelle L. Butler – On September 27th, FDA published a guidance document regarding user fee waivers, reductions, and refunds for drug and biological products. See 76 Fed. Reg. 59705 (Sept. 27, 2011); FDA, Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and …
By Kurt R. Karst – With each stroke of the pens President Obama used to sign into law the Leahy-Smith America Invents Act, it seemed as though another nail was hammered into the coffin of any attempts to deny The Medicines Company (“MDCO”) a win in …
By Kurt R. Karst – Generic Pharmaceutical Association (“GPhA”) Board of Directors Chairman Paul Bisaro recently sent a letter to members announcing both the completion of the negotiating phase (see here and here) of what is intended to become the Generic Drug User Fee Act (“GDUFA”) …
By Kurt R. Karst – On September 19th, FDA announced the issuance of a revised version of the Agency’s June 2006 final guidance document/Compliance Policy Guide (“CPG”) (FDA Docket No. 2003D-0478), titled “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved …
By Anne Marie Murphy – FDA and the Office for Human Research Protections ("OHRP") have jointly announced the issuance of a draft guidance document on “Exculpatory Language in Informed Consent.” HHS and FDA regulations have long prohibited the use “exculpatory language” in informed consent documents for clinical research …
By Karla L. Palmer & Jeffrey N. Gibbs – Marking a significant victory for the pharmaceutical compounding industry, a Florida federal district court ruled that FDA did not have authority to enjoin the “long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food …
