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 Ricardo Carvajal – The question (in the title of this post) occurred to us in preparing for FDLI Food Week 2015, taking place as this is written. When FDA issued its Pathway to Global Product Safety and Quality in 2011, the agency set forth this ambitious objective: …
By Jamie K. Wolszon – Amidst the winter storms that have struck the East Coast this January and February, there has been, and will continue to be, a flurry of developments related to FDA efforts to actively regulate Laboratory-Developed Tests (LDTs). Those developments include a White …
By Frank J. Sasinowski & Andrew J. Hull* – Even though we often blog on orphan drug developments (see two of our most recent posts here and here), many may be unaware of the origin of the term “orphan.” Today, we may think that the term …
By Karla L. Palmer – Following our blogpost describing the four human drug compounding draft guidance documents and draft Memorandum of Understanding (MOU) that FDA released last Friday, FDA formally published the documents in the Federal Register on February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 …
By Douglas B. Farquhar, Jennifer M. Thomas & Kurt Karst – We can’t help celebrating a recent court victory in which Hyman, Phelps & McNamara, P.C. represented Mylan Pharmaceuticals, Inc. (“Mylan”), and which yesterday resulted in Final Approvals for Mylan and one other generic drug company …
By Ricardo Carvajal – Given the effort that FDA has put into FSMA implementation thus far, it comes as no surprise that the agency’s budget for 2016 places a heavy emphasis on the resources that the agency believes are needed to finish the job. The focus on FSMA …
