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By Dara Katcher Levy – Last Friday, FDA issued the latest in a series of draft guidance documents (here and here) that address alternate ways companies can disclose risk information in consumer-directed print Rx drug promotion.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 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 …
By Kurt R. Karst – There was some big news out of FDA today. Yes, there was the news that FDA Commissioner, Dr. Margaret Hamburg, one of the longest-serving FDA commissioners in the modern era (see here), has decided to resign her post effective next month. …
By James C. Shehan – The new Congress has been very busy introducing legislation that affects FDA and regulated industry, including the 21st Century Cures Act (see our previous post here); the Limited Population Pathway for Antibacterial Drugs Act (PATH) (here) and the Improving Regulatory Transparency …
By Kurt R. Karst – There’s no two ways about it: We love data. And it doesn’t really matter what FDA-related topic those data concern: citizen petitions (here and here), drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation …
By James E. Valentine* & Anne Marie Murphy – The first month of 2015 has seen two policy proposals that would expand clinical trials data sharing. On January 14, the Institute of Medicine (“IOM”) released its report on “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks,” …
By Kurt R. Karst – For months we have been waiting with bated breath for the promised January 2015 release of a discussion draft of legislation to implement the 21st Century Cures Initiative, which was launched in April 2014 by now-Chairman of the House Energy and …
By Kurt R. Karst – Earlier today (January 26, 2015), FDA announced the first approval of an ANDA for a generic version of AstraZeneca Pharmaceuticals LP's (“AstraZeneca's”) NEXIUM (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg. But it wasn’t Ranbaxy Laboratories, Ltd./Ranbaxy, Inc. (“Ranbaxy”) that scored …
By Kurt R. Karst – It’s been a little more than 2.5 years since Section 505(w) was added to the FDC Act by Section 1134 of the 2012 FDA Safety and Innovation Act (“FDASIA”). Section 505(w), titled “Deadline For Determination on Certain Petitions,” requires FDA to …
By Anne K. Walsh – This post relates to the all-important package insert, which provides health care professionals with the latest information about the approved uses of a prescription drug or biological product, as well as information necessary for the safe and effective use of the …
