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 …
There is a rather memorable (and hilarious) scene from the movie “Good Morning, Vietnam” in which Robin Williams (playing the role of Airman First Class and disc jockey Adrian Cronauer) questions an Army lieutenant about a 1965 press conference to be given by former Vice …
Hyman, Phelps & McNamara, P.C. (“HPM”) is happy to announce that 4 of the firm’s attorneys have been named Super Lawyers in the Washington, D.C., area. The March 2008 edition of Washington, D.C. Super Lawyers identifies 17 Super Lawyers from the Food and Drug Bar. …
On February 4, 2008, FDA announced that the Bush Administration is requesting nearly $2.4 billion ($1.77 billion in budget authority and $628 million in user fees) for the Agency as part of the Fiscal Year 2009 budget. Of particular interest in the proposed FY2009 budget …
Over the past few weeks, Congress has taken an acute interest in a broad range of FDA issues and FDA-regulated products, penning several letters and holding or expressing intent to hold hearings and investigations on various matters. Below is a list of recent congressional activity: On …
On January 8, 2008, the District of Columbia Council passed the SafeRx Act of 2007 (“Act”), which requires pharmaceutical detailers to be licensed by the Board of Pharmacy. The Act will be presented to Mayor Adrian Fenty for his signature and then to Congress if …
On February 8, 2008, Hyman, Phelps & McNamara, P.C. (“HPM”) is sponsoring a Medical Device Seminar in Newport Beach, California. The topic of this seminar will be “Striving for Regulatory Success in a Changing Environment.” Scheduled speakers for the seminar are Jeff Gibbs, Brian Donato, …
Last week, the United States Court of Appeals for the Seventh Circuit concluded that the Federal Trade Commission Act (“FTC Act”) does not require placebo-controlled, double-blind testing for consumer products. The ruling, issued in Federal Trade Commission v. QT Inc., upheld a decision by the …
In our second installment of the “Lighter Side” (our first post is available here) we pass along to you an article from The Birmingham News, which reported on a comical case of a “shaming penalty” the CEO of a medical device company agreed to as …
