Hyman Phelps McNamara

By Kurt R. Karst –       Every once in a while we receive a series of similar questions from various quarters such that a critical mass has been reached justifying a blog post on the topic.  This is one of those posts.  And it has to do …

By Kurt R. Karst – Although the number of cases involving 180-day exclusivity under the version of the FDC Act in effect before the December 8, 2003 enactment of the Medicare Modernization Act (“MMA”) is nearing an end, the pre-MMA statute, and the handling of it …

By Jeffrey K. Shapiro – FDA has enhanced authority over the sale, distribution and use of devices that the agency designates as “restricted.”  21 U.S.C. § 360j(e).  FDA almost always designates Class III devices as “restricted devices” in premarket application (“PMA”) approval orders.  21 U.S.C. …

By Ricardo Carvajal – FDA released two long-awaited proposed rules to implement key provisions of the Food Safety Modernization Act ("FSMA"): Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce …

By Jennifer D. Newberger – On December 31, 2012, CDRH released three final guidance documents, the drafts of which were issued in the summer and fall of 2012.  The quick finalization of these guidance documents is likely due to their fairly uncontroversial nature, since they are …

By Kurt R. Karst –       Last week in a post-Christmas decision, Judge John D. Bates of the U.S. District Court for the District of Columbia granted both FDA’s and Intervenor-Defendant Ranbaxy Laboratories Limited’s (“Ranbaxy’s”) Motions for Summary Judgment and denied Mylan Laboratories Limited’s and Mylan …

By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published its long awaited notice of proposed rulemaking to implement the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”).  77 Fed. Reg. 75,784 (Dec. 21, 2012).  Interested persons should submit electronic comments on …

By Ricardo Carvajal – Signaling potential movement on an issue that has bedeviled industry, FDA published a notice requesting comments “relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens.”  Undeclared major food allergens continue to be one of the two principal …

By Jennifer D. Newberger & Jeffrey N. Gibbs – A quick Google search of “dog trained to identify medical conditions” indicates that, around the world, dogs are already working with people to help sniff out certain medical conditions.  For example, in the United Kingdom an organization …

By Riëtte van Laack – District Judge Susan Nelson of the District of Minnesota recently concluded that FDA is best qualified and has been authorized by Congress to decide whether Milk Protein Concentrate (“MPC”) is a “proper, permitted ingredient in yogurt.”  Earlier this year, on March …

Hyman, Phelps & McNamara, P.C. is pleased to announce that Diane B. McColl has been elected to serve as the new President of the International Society of Regulatory Toxicology and Pharmacology (“ISRTP”).  ISRTP’s mission is to provide an open public forum for policy makers and …

By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking in the December 19th Federal Register (77 Fed. Reg. 75,075 (Dec. 19, 2012)) to place lorcaserin into schedule IV of the federal Controlled Substances Act (“CSA”).  Interested persons must …

Hyman, Phelps & McNamara, P.C. Director David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products.  The conference, titled “EU and US Regulatory Issues for IP Professionals,” will take …

By Kurt R. Karst –       The Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) share some common ground.  All three of the trade groups oppose a Safe Drug Disposal Ordinance (see here and here [Item …

By Alexander Varond – On December 14, FDA released a draft guidance document entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Enrichment Guidance”).  The thirty-nine-page document was more than six years in the making and aims to provide …