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    • Congress Enacts Legislation to Strengthen CPSCAugust 17th, 2008

      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 …

    • A Noteworthy Event for the Drug and Device IndustriesAugust 15th, 2008

      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 …

    • FDA Announces Public Meeting and Request for Comments and Data on NanotechnologyAugust 7th, 2008

      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) …

    • Update: FDA Globalization Act Discussion Draft RevisedAugust 4th, 2008

      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 …

    • PhRMA Releases Revised “Code on Interactions with Healthcare Professionals” that is More Restrictive than the July 2002 Version; HP&M Issues Summary MemorandumJuly 10th, 2008

      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 …

    • Come Work for HP&M — Hosts of FDALawBlog.NetJune 16th, 2008

      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 …

    • “Andy’s Take” (‘Nuff Said)April 1st, 2008

      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 to Hold Joint Interactive Forum on Generic DrugsMarch 26th, 2008

      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 …

    • HPM Announces that Ricardo Carvajal has Joined the Firm as Of CounselMarch 18th, 2008

      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 …

    • The Lighter Side of Food & Drug Law: FDA From A-V to YTDMarch 13th, 2008

      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 …

    • It’s a Bird, It’s a Plane, It’s a Super-Lawyer! (Actually, 4 of Them!)March 12th, 2008

      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.  …

    • President Bush Proposes FY2009 FDA Budget; Follow-On Biologics and New User Fee Legislation on Tap for 2008, as Well as Plans to Resurrect FDAAA DTC TV Ad User Fee ProgramFebruary 5th, 2008

      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 …

    • Hot & Bothered – Congress Sends Out Yet Another Missive Concerning FDAJanuary 31st, 2008

      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 …

    • D.C. Council Passes SafeRx Act; Requires Licensing of Pharma DetailersJanuary 11th, 2008

      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 …

    • HPM Holds Medical Device Seminar in California – Register Today!January 9th, 2008

      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, …