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 …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Melisa M. C. Moonan has joined the firm as Of Counsel. Ms. Moonan advises clients on medical device regulatory issues. She joined the firm after close to six years as Associate Chief Counsel for Regulatory …
By Kurt R. Karst – Last week, the folks over at the Big Molecule Watch Blog broke the news that the U.S. District Court for Southern District of Florida (Judge James I. Cohn) ruled on a Motion for Preliminary Injunction (supplemented) filed by Amgen, Inc. and …
By Alan M. Kirschenbaum – If you’re looking for Holiday reading, CMS has a gift for you! OMB’s Office of Information Regulatory Affairs (OIRA) has completed its review of a long-awaited CMS final regulation implementing significant changes to the Medicaid Drug Rebate Program. Completion of the review …
By Alexander J. Varond – On December 8, 2015, FDA approved two new therapies: Vonvendi (BLA 125577) for von Willebrand disease and Kanuma (NADA 141-453) for lysosomal acid lipase (LAL) deficiency. These approvals bring the number of new molecular entities and new therapeutic biological products approved this …
By James C. Shehan – In a citizen petition (Docket No. FDA-2015-P-4529) posted earlier this week, a group of fifteen institutional investors asked FDA to require that all approved prescription drug labeling for biosimilar and interchangeable biological products follow the “same labeling” approach that the agency applied …
By Riëtte van Laack – Although it has taken some time, the Food Safety and Inspection Service (FSIS) of the USDA published a final rule establishing a mandatory inspection program for “catfish (“fish of the order Siluriformes and products derived from these fish.”) This rule implements …
By Jay W. Cormier – On December 8, 2015, FDA issued a complex set of approvals for a unique product, Kanuma (sebelipase alfa). Kanuma is indicated for the treatment of a rare disease known as lysosomal acid lipase (LAL) deficiency. The list of distinguishing descriptors for the …
By Kurt R. Karst – Earlier this week, Public Citizen announced the release of a report, titled “House Orphan Drug Proposal: A Windfall for Pharma, False ‘Cure’ for Patients,” that takes aim at a particular provision in the 21st Century Cures Act (H.R. 6) that the …
