Earlier this month, European drug makers called on the European Union (“EU”) to act on the issue of parallel trading of pharmaceuticals by confining prices for drugs to the specific EU member country they are initially sold. Drug makers argue that some form of price …
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Anne Marie Murphy and Michelle L. Butler have been named Directors of the firm, and that Larry K. Houck has been named Of Counsel. Ms. Murphy’s practice focuses on drug development issues. She serves …
Inside Health Policy recently reported on the writings of several professors who opined on courts’ deference to the FDA. The writings discussed in the Inside Health Policy piece were from the July 2008 Cornell Law Review, which devoted an entire issue to “Symposium: U.S. Food …
As any blogger can tell you, writing a blog is a labor of love. It takes a lot of time to put together thoughtful and informative posts – and before the news gets stale. So, when our blog is mentioned as one of the top …
Jeffrey K. Shapiro of Hyman, Phelps & McNamara, P.C. will be speaking at American Conference Institute’s 8th National Conference on Reducing Legal Risks in the Sale and Marketing of Medical Devices, November 17-18, 2008 at the Allerton Hotel on the Magnificent Mile in Chicago, IL. …
Kurt R. Karst of Hyman, Phelps & McNamara, P.C. (and co-chief blogger of FDALawBlog.net) will be speaking at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes, October 15 – 16, 2008, at the Marriott Philadelphia Downtown in Philadelphia, Pennsylvania. A copy of …
On August 14, 2008, the President signed into law Public Law No. 110-314, the Consumer Product Safety Improvement Act of 2008. The new law contains a number of provisions relating to children’s products, including lead. It also contains provisions relating to the administrative functions that …
Robert A. Dormer of Hyman, Phelps & McNamara, P.C. will be speaking at American Conference Institute’s FDA Boot Camp conference, September 22-23, 2008 at the Sheraton Boston Hotel in Boston, MA. Click here for a copy of the agenda. At the event, preeminent members of the …
On September 8, FDA will hold a public meeting to receive data and other information on the effects of nanoscale materials on quality, safety, and effectiveness of FDA-regulated products. FDA will consider the information that it receives in its development of guidance that addresses: (1) …
Representative John Dingell (D-MI) has revised several of the drug-related sections of the Discussion Draft of the FDA Globalization Act (“FDAGA”). We first reported on the Discussion Draft, which has received significant attention from industry and stakeholder groups alike, in April 2008. Updated sections of the …
On June 10, 2008, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) announced the release of a newly revised version of the “Code on Interactions with Healthcare Professionals,” which is a voluntary code focusing on the industry’s interactions with healthcare professionals as they relate to …
Hyman, Phelps & McNamara, P.C., the nation’s largest dedicated food and drug practice, seeks a mid-level associate experienced in drug/biologics development and approval for our D.C. office. The ideal candidate will have a scientific or medical background and prior regulatory experience in drug/biologics development issues …
Welcome to the wonderful world of blogging, Dr. von Eschenbach! Yep, just like his boss, Department of Health and Human Services Secretary Michael Leavitt, who started “Secretary Mike Leavitt’s Blog” last year, FDA Commissioner, Dr. Andrew von Eschenbach, has started a blog as well – …
FDA and the University of Rhode Island College of Pharmacy will co-sponsor an interactive forum from June 30 through July 1, 2008 at the Hyatt Regency in Bethesda, Maryland on how and how not to communicate with FDA’s Office of Generic Drugs (“OGD”). Forum presenters …
Hyman, Phelps & McNamara, P.C. (“HPM”) is pleased to announce that Ricardo Carvajal has joined the firm as Of Counsel. From 2002 to 2007, Mr. Carvajal served as Associate Chief Counsel in FDA’s Office of Chief Counsel, where he handled issues concerning foods (including conventional …
