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    • HP&M’s Diane B. McColl Tapped to Be VP of ISRTPMarch 21st, 2011

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

    • Red Flags Rule Battle Appears to Come to a CloseMarch 7th, 2011

      By William T. Koustas – We have previously reported on the long running legal battle between the Federal Trade Commission (“FTC”) and the American Bar Association (“ABA”) over the implementation of the FTC’s Red Flags Rule (“the Rule”).  Last Friday, the United States Court of Appeals …

    • FDA Law Blog Turns 4!March 4th, 2011

      Whether you say it in English, German (“Alles Gute zum Geburtstag FDA Law Blog!”), Hebrew (“Yom Huledet Same'ach FDA Law Blog!”), Hindi (“Janam Din ki badhai FDA Law Blog!”), Japanese (“Otanjou-bi Omedetou Gozaimasu FDA Law Blog!”), Zulu (“Ilanga elimndandi kuwe FDA Law Blog!”), or any …

    • California Requires Businesses to Address International Slavery and Human TraffickingJanuary 6th, 2011

      By James R. Phelps – California's SB 657, adopted in 2010, enlists manufacturers and retailers of goods with annual worldwide gross receipts over $100 million in the effort to eradicate “slavery and human trafficking.”  They are to provide information on …

    • HPM Announces that Anne K. Walsh has Joined the Firm as Of CounselJanuary 4th, 2011

      Hyman, Phelps & McNamara, P.C. (“HPM”) is pleased to announce that Anne K. Walsh has joined the firm as Of Counsel.  Prior to joining the firm in January 2011, Ms. Walsh served as an Associate Chief Counsel with the U.S. Food and Drug Administration’s Office …

    • HP&M Attorney Elected VP of ISRTP CouncilDecember 16th, 2010

      Hyman Phelps & McNamara, P.C. is pleased to announce that Diane B. McColl has been elected Vice-President of the Council of the International Society for Regulatory Toxicology and Pharmacology (“ISRTP”).   ISRTP provides an open public forum for policy makers and scientists promoting sound toxicologic and …

    • Congress Passes Legislation to Alter Red Flags RuleDecember 9th, 2010

      By William T. Koustas – The Red Flags Rule (“the Rule”) requires entities covered by it to establish and implement an identity theft prevention program.  We have been following this issue for some time now and have previously reported that the FTC last delayed enforcement of …

    • FDA Publishes Annual Guidance AgendaDecember 8th, 2010

      By Ricardo Carvajal – As required by its Good Guidance Practices regulation, FDA published its annual guidance document agenda and request for comment on “possible topics for future guidance document development or revisions of existing [guidance documents].”  Among the food-related topics that caught our eye are new …

    • A Repeat! ABA Journal Names FDA Law Blog to “Blawg 100”November 30th, 2010

        Thanks to our faithful readers, we made the list for the annual American Bar Association (“ABA”) Journal Blawg 100 for the second year in a row.  The editors of the ABA Journal announced the top 100 best law blogs by lawyers, for lawyers earlier this …

    • Hyman, Phelps & McNamara, P.C. Announces New Director and Of CounselNovember 15th, 2010

      Hyman, Phelps & McNamara, P.C. is very pleased to announce that Ricardo Carvajal has been named Director of the firm, and that Dara Katcher Levy has been named Of Counsel.  Mr. Carvajal’s practice focuses on providing FDA and FTC regulatory counseling and litigation support to …

    • HP&M’s Frank Sasinowski Added to Biotech Company’s “Wall of Honor”October 29th, 2010

      On Thursday, United Therapeutics Corporation (“UTC”), a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions, unveiled a plaque honoring HP&M Director Frank Sasinowski for his contributions to UTC’s development …

    • Proposed FTC Green Guides are Greener (Just Don’t Print All 229 Pages of It)October 7th, 2010

      By Carrie S. Martin – Yesterday, the Federal Trade Commission (“FTC”) announced the issuance of proposed revisions to its “Green Guides,” last revised in 1998.  The proposed revisions would update industry guidance on how to avoid making misleading environmental claims.  In addition, Julie Brill, Commissioner of …

    • HP&M Attorney to Speak at CBI Paragraph IV Disputes ConferenceOctober 5th, 2010

      Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be speaking at the Center for Business Intelligence’s (“CBI’s”) 3rd Annual Life Sciences Congress on Paragraph IV Disputes, which is scheduled for October 18-19, 20109 at the Hilton Alexandria Old Town in Alexandria, Virginia.  This popular …

    • California’s Green Chemistry Regulations; A Lot of R&R (Requirements and Responsibilities) for Regulated IndustrySeptember 28th, 2010

      By Randy Pollack*, Wes Siegner & Brian J. Donato – In September 2008, California Governor Arnold Schwarzenegger signed landmark green chemistry legislation authorizing the Department of Toxic Substance Control (“DTSC”) to: (1) identify and prioritize chemicals of concern, evaluate alternatives as well as to specify regulatory …

    • HP&M Presents the Evolution of FDA and the Park DoctrineSeptember 21st, 2010

      Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic.  You can register for the free webinar here.  (Please register by September 29th.) In criminal prosecutions of corporate executives, ignorance of …