Hyman, Phelps & McNamara, P.C.’s David B. Clissold has been named to the Board of Advisors of Analgesic Clinical Trial Innovations, Opportunities, and Networks (“ACTION”). ACTION is a public-private partnership aligned with FDA’s recently launched Initiative for the Advancement of Regulatory Science. ACTION is designed …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Linda S. Carter will join the Firm as a Regulatory Scientist on April 19th. Linda, who will primarily assist HP&M’s drug development group, brings significant experience and expertise in shaping regulatory policies, particularly Comparative Effectiveness …
Have you been looking for that one, comprehensive publication that covers intellectual property and patent law issues in the pharmaceutical, biotechnology and chemical industries from around the world’s key jurisdictions? Well, it’s finally here – or will be in the next month or so when …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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. 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 …
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 …
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 …
