By Kurt R. Karst – In a Per Curiam Judgment handed down last month, the U.S. Court of Appeals for the District of Columbia Circuit affirmed District Court Judge Ketanji Brown Jackson’s January 2015 ruling upholding FDA’s September 26, 2014 approval of a 505(b)(2) application (NDA …
By Jay W. Cormier – As readers of this blog may recall, FDA observed remarkable conditions at two facilities on the NIH campus in Bethesda, MD (see our post here). Then, earlier this year, NIH stated again that it was closing its drug manufacturing facilities (see …
By Karla L. Palmer – FDA announced last week the availability of a draft guidance document titled, “Insanitary Conditions at Compounding Facilities.” This draft is FDA’s first attempt to assist compounding facilities and state regulators in identifying “insanitary conditions so they can implement appropriate corrective actions.” …
A breakthrough paper by Hyman, Phelps & McNamara, P.C’s Frank Sasinowski and Alexander Varond concerning FDA’s Subpart H approvals has just published in the Food and Drug Law Journal. Titled “FDA’s Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence,” the paper examines the …
By Kurt R. Karst – Like the Running of the Bulls in Pamplona, Spain each Summer, we wait with bated breath each July and August to see how FDA-regulated companies might get gored when FDA releases the user fee rates for the next fiscal year. Over …
By Kurt R. Karst – Late last week, Judge Ketanji Brown Jackson of the U.S. District Court for the District of Columbia issued a 57-page Memorandum Opinion handing FDA a victory on the scope of 3-year new clinical investigation exclusivity. The decision came in a case …
By Kurt R. Karst – We recently posted on an orphan drug clinical superiority precedent we came across: PURIXAN (mercaptopurine) Oral Suspension, 20 mg/mL, for the treatment of Acute Lymphoblastic Leukemia in pediatric patients. It’s the sixth “greater safety” orphan drug clincial superiority precedent we know …
by Alan Kirschenbaum and Michelle Butler On July 14, 2016, CMS issued a release to manufacturers regarding value-based purchasing (VBP) arrangements. The purpose of the release is to (1) inform manufacturers how to seek guidance from CMS regarding the impact such arrangements might have on the …
By Karla L. Palmer FDA published for comment two non-binding draft guidance documents addressing compounding of commercially available drug products by traditional pharmacies under FDCA Section 503A and outsourcing facilities under Section 503B. [Section 503A Draft Guidance is HERE, blogged separately] and Section 503B Guidance is …
By Karla L. Palmer – On July 11, 2016, FDA published for comment two draft guidance documents addressing compounding of commercially available drug products by traditional pharmacies under FDCA Section 503A and outsourcing facilities under Section 503B (the Section 503A Draft Guidance is available here …
By Kurt R. Karst – It’s been a while since we posted on a 180-day exclusivity forfeiture issue, though we suspect that we’ll be doing it more in the coming months with some interesting issues on the horizon. But for now, FDA Blog Readers will have …
By Kurt R. Karst – We like hunting down orphan drug clinical superiority precedents. And although it’s been said that “the thrill is in the chase, never in the capture” (by a Doctor Who character at least), we enjoy the capture just as much as the …
In recent years, the level of scrutiny of foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand for and dependence of Western countries on the supply of goods coming from those facilities. A recent webinar, International Pharmaceutical Supply Chain Imperiled …
By Kurt R. Karst – First, FDA gets hit with a June 27th preemptive lawsuit over approval of generic versions of CRESTOR (rosuvastatin calcium) Tablets; and then, on June 28th, a second lawsuit is filed by Lannett Company Inc. and Lannett Holdings, Inc. (collectively “Lannett”) challenging FDA’s …
By Kurt R. Karst – For several years now, the Obama Administration’s annual budget requests (here, here, and here, for example) have included proposals to reduce to 7 years the current 12-year period of Reference Product Exclusivity (“RPE”) for biological products licensed under Section 351(a) of …
