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 …
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 …
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 …
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 …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce that the inaugural “Best Law Firms” survey by U.S. News & World Report has ranked HP&M as a “Tier 1” law firm in the area of FDA Law. Only six firms made it to the top …
It’s that time of year again when the Blawggeratti (legal bloggers) are all atwitter about the American Bar Association’s (“ABA’s”) Blawg 100 – the top 100 legal blogs in the blogosphere. With your help we made the top 100 list last year, and we are …
By Ricardo Carvajal – According to one working definition, synthetic biology encompasses "the design and fabrication of biological components and systems that do not already exist in the natural world" and "the re-design and fabrication of existing biological systems." Recent developments in the field prompted …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Karla L. Palmer will join the Firm as a Director on Monday. Karla brings significant experience in civil and administrative litigation matters. At Hyman, Phelps & McNamara, she will focus on a wide range of …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Diane B. McColl has been elected to the U.S. Pharmacopeial Convention’s (“USP’s”) Expert Committee for the Food Chemicals Codex (Monographs – Food Ingredients) for the 2010-2015 cycle. The committee develops new monographs and revises …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Frank J. Sasinowski has been elected by the the U.S. Pharmacopeial Convention (“USP”) as an At-Large Trustee of the USP Board of Trustees for the 2010-2015 cycle. The Board of Trustees will guide the activities …
By William T. Koustas – As we have previously reported (here, here, and here), the FTC has delayed enforcement of its Red Flags Rule (“the Rule”) several times since its original effective date of November 1, 2008. Now, some in Congress have requested that the …
By Ricardo Carvajal – FDA’s approach to regulation of nanotechnology has remained essentially unchanged since the issuance of the agency’s Nanotechnology Task Force Report in 2007. In that report, which was endorsed by then-Commissioner von Eschenbach, FDA declined to adopt a formal definition of nanotechnology, …
Yep, it’s been three years since we started FDA Law Blog. And that means it’s time again to take a minute from blogging on FDA issues to pat ourselves on the back. It’s been a banner year for us. We recently topped 800 posts (almost …
For heavily-regulated companies, such as those regulated by the Food and Drug Administration, it is common for companies to seek advice from in-house and outside counsel regarding whether proposed conduct would violate the law. It has become increasingly popular for federal prosecutors to target the …
