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By Dara Katcher Levy – Last Friday, FDA issued the latest in a series of draft guidance documents (here and here) that address alternate ways companies can disclose risk information in consumer-directed print Rx drug promotion.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 …
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 …
Attached here is the obituary of Frank Hurley, as issued by his company RRD International. Frank was a Co-Founder of RRD as well as its Chairman and Chief Scientific Officer. The obituary’s rich detail correctly describes his professional reputation as the premier innovator in his …
By John R. Fleder & Riëtte van Laack – On Friday, January 30, almost nine months after the oral argument, the U.S. Court of Appeals for the D.C. Circuit issued its Opinion in POM Wonderful Inc. v. FTC. We have previously blogged on this case (see …
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,” …
