By James C. Shehan – The worlds of FDA regulatory law and employment law rarely intersect, so when we came across a recent case in which they did, we thought it worthy of commentary. In that case, a federal appeals court held that GMP troubles leading …
By Allyson B. Mullen – In August, CDRH quietly implemented a new version of the 510(k) Refuse to Accept (RTA) Policy in a draft guidance, titled "Refuse to Accept Policy for 510(k)s" (New RTA Guidance). This change was done with so little fanfare that many did not …
By Riëtte van Laack – On December 23, 2015, FDA issued a proposed rule amending the regulations for prescription and over-the-counter (OTC) fixed-combination products, co-packaged drugs, and combinations of active ingredients under consideration for inclusion in an OTC monograph. The 20-page proposal is intended to harmonize …
By Riëtte van Laack – “Native advertising” is advertising that looks like “news, feature articles, product reviews, entertainment, and other material surrounding it.” In the digital context, native advertising constitutes marketing material that is designed to mimic the look and feel of the host website. It …
By Alexander J. Varond – On December 18, Congress extended the rare pediatric disease priority review voucher (pediatric PRV) program out to September 30, 2016. The extension was granted as part of Congress’s budget deal. Although modest, it has been welcomed by industry. Many hope, however, …
By Kurt R. Karst – The once nascent biosimilars industry took off in 2015 with the first biosimilar approval (ZARXIO [filgrastim-sndz], which FDA licensed on March 6, 2015 under BLA 125553), myriad court decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) (see …
By James E. Valentine & David B. Clissold – In an annual update presented at the FDA/CMS Summit on December 14, 2015, Dr. John Jenkins, Director, Office of New Drugs, the Center for Drug Evaluation and Research (CDER or the Center), provided metrics and insights into …
By Kurt R. Karst – Congress has been busy in the lead-up to the holiday! In addition to the recently-enacted 2016 Consolidated Appropriations Act, which saddles FDA will meeting myriad requests and new requirements, a host of lawmakers from the U.S. House or Representatives recently sent …
The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 27th iteration, is slated to take place at The Carlton Hotel in New York, New York from March 9-11, 2016. The conference is billed as the premier event to provide folks with a …
By Jamie K. Wolszon & Jeffrey N. Gibbs – As 2015 draws to a close, the world of laboratory-developed test regulation continues in high gear. One major event featured the Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren testifying last month before the House …
Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro participated in a panel discussion at a recent Food and Drug Law Institute conference that focused on the regulation of digital health software. Mr. Shapiro’s talk emphasized the limits of FDA’s expertise and the need for caution …
By Riëtte van Laack – The Supreme Court of California recently concluded that federal law does not preempt claims against allegedly intentional misrepresentations of organic status of a food. According to the Court, the Organic Foods Production Act of 1990 (OFPA) only preempts state law on …
By Ricardo Carvajal – Answer: They were all designated as high priority items in a Nutrition Program Review (NRP) Report prepared by CFSAN staff for the Center Director in December 2014. (We compiled the report and its attachments into a single PDF, which we repaginated for …
By Larry K. Houck – The Centers for Disease Control and Prevention (“CDC”) have published draft guidelines for prescribing opioids for chronic pain and opened a docket seeking public comment. Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain, 80 Fed. Reg. 77,351 (Dec. 14, 2015). …
By David C. Gibbons & Jeffrey N. Wasserstein – Pacira Pharmaceuticals, Inc. (“Pacira” or the “Company”) announced today that it had reached agreement with FDA to settle its First Amendment challenge regarding the promotion of its drug, EXPAREL. As we discussed in a previous post, Pacira …
