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By Karla L. Palmer – Following our blogpost describing the four human drug compounding draft guidance documents and draft Memorandum of Understanding (MOU) that FDA released last Friday, FDA formally published the documents in the Federal Register on February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 …
By Jennifer D. Newberger – On February 9, less than a year after issuing the draft, FDA issued a final guidance document confirming its exercise of enforcement discretion with respect to medical device data systems (MDDS), medical image storage devices, and medical image communications devices. In …
By Dara Katcher Levy – Last Friday, FDA issued the latest in a series of draft guidance documents (here and here) that address alternate ways companies can disclose risk information in consumer-directed print Rx drug promotion. The most significant difference between the 2015 and 2004 draft …
By Jay W. Cormier & Allyson B. Mullen – Two years ago, FDA promulgated the Part 4 regulations that specify how manufacturers of combination products are to comply with current good manufacturing practice (cGMP) when making products whose constituent parts are from more than one type …
By James E. Valentine* & Jim C. Shehan – The 21st Century Cures Act’s focus on patients is inescapable. Title I of this nearly 400 page bill is entitled, “Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process and Addressing Unmet Needs.” When we reported …
