By Josephine M. Torrente & James E. Valentine* – On March 9, 2015, FDA announced the availability of draft guidance which allows the use of electronic informed consent (“electronic IC”) in FDA-regulated clinical investigations of medical products (and the use of electronic assent in pediatric studies). …
By Kurt R. Karst – That’s right folks, another Golden Ticket has been awarded! On March 10, 2015, FDA approved BLA 125516 for United Therapeutics Corporation’s (“UTC’s”) Unituxin (dinutuximab) in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2 and 13-cis-retinoic acid, for the treatment of pediatric patients with …
By Karla L. Palmer – On Monday, March 9th FDA published a notice in the Federal Register establishing a public docket to receive information, recommendations, and comments on matters related to the regulation of compounding of human drug products under FDCA sections 503A and 503B. …
By Kurt R. Karst – Every once in a while FDA gets asked a question along the lines of: “Can my company submit two ANDAs to FDA – from two different subsidiaries – each containing the same bioequivalence data?” . . . or “Can my company …
By Kurt R. Karst – Amidst concern that the 2013 sequester could make a repeat appearance and reduce both FDA’s budget from Congress and industry-financed user fees to the Agency, Representatives Anna Eshoo (D-CA) and Leonard Lance (R-NJ) have introduced legislation to exempt FDA user fees …
By Kurt R. Karst – There’s been a lot of activity in the budding biosimilars world this year, and it’s only February. On the FDA front, the Agency reportedly has 5 Section 351(k) biosimilars applications under review: (1) Sandoz’s version of Amgen’s NEUPOGEN (filgrastim); (2) Celltrion’s …
By Kurt R. Karst – In a 19-page decision handed down earlier this week by Judge Nancy Torresen of the U.S. District Court for the District of Maine, the court ruled that Maine’s 2013 law, titled “An Act To Facilitate the Personal Importation of Prescription Drugs …
By Kurt R. Karst – It’s been a long time since we last posted on a Patent Term Extension (“PTE”) controversy – a little more than a year it seems (see here) – but that doesn’t mean we’re not keeping an eye on decisions coming out …
By Karla L. Palmer – Following our blogpost describing the four human drug compounding draft guidance documents and draft Memorandum of Understanding (MOU) that FDA released last Friday, FDA formally published the documents in the Federal Register on February 19th. Interested persons should note the docket …
By Kurt R. Karst – Without even knowing what we’re talking about, it’s probably safe to say that any company would immediately answer “Yes!” to the question posed in the title to this post. But that’s exactly what FDA is asking some ANDA applicants to do …
By Kurt R. Karst – Last year we posted on the possible effect of Inter Partes Review (“IPR”) on the forfeiture of 180-day exclusivity eligibility under the so-called failure-to-market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I) added by the 2003 Medicare Modernization Act. With no decision …
By Karla L. Palmer – As it did on the eve of another holiday weekend last July (see our previous posts here and here), on this past Friday (the 13th), FDA released the long-awaited draft Memorandum of Understanding (MOU) addressing interstate shipment of compounded preparations under …
By Kurt R. Karst – Earlier this month in a post concerning the Orange Book we mentioned our love of data and discussed how solid figures can reveal some interesting conclusions. After all, it’s rather difficult – and dangerous – to come to a conclusion without …
By James E. Valentine* & Anne Marie Murphy – The National Institutes of Health (“NIH”) just extended the comment period for its Notice of Proposed Rulemaking on clinical trial registration and results submission (“NPRM”) until March 23, 2015. As we previously reported, the NPRM proposes to …
By Kurt R. Karst – For those in the generic drug industry who attended the Generic Pharmaceutical Association’s (“GPhA’s”) annual meeting in Miami, Florida earlier this week, the message from Office of Generic Drugs (“OGD”) Director Dr. Kathleen “Cook” Uhl in her Generic Drug User Fee …
