Today, FDA announced updated guidance regarding its MoCRA rollout. FDA  does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements. To read the full text ..read more

On November 7, 2023, the Federal Trade Commission (“FTC”) announced that it had issued notice letters to 10 life sciences companies regarding 100 patents that the FTC contends are improperly listed in the Orange Book, the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. The announcement comes of the heels of the FTC’s policy statement ..read more

Daniel R. Pierce, Corporate and IP partner in the Boston office, recently spoke with Chris Barden, CEO of firm client Treventis, about his background, his company’s research into misfolded proteins to develop cures for central nervous system diseases like Alzheimer’s, as well as Chris’ thoughts and experience at the BIO Conference. Can you tell us ..read more

In Episode 35 of the  Class Action Weekly Wire podcast,  host Jerry Maatman interviews Duane Morris associate Kelly Bonner about the Modernization of Cosmetics  Regulation Act (MoCRA). Watch the episode below ..read more

Duane Morris attorneys Rick Ball and Coleen Hill will be speakers at MassMEDIC’s Regulatory Roundup, to be held on November 15, 2023 from 8:00 a.m. to 4:15 p.m.  Rick and Coleen will present “When Things Go Wrong: Navigating Enforcement When the FDA, SEC, and DOJ Are All Involved.” For more information and to register for ..read more

On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisan and industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers and distributors of ..read more

On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process.  Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety.  In ..read more

On September 21, 2023, the Federal Trade Commission sued U.S. Anesthesia Partners Inc. and Welsh, Carson, Anderson & Stowe XI L.P., among other private equity funds, in the United States District Court for the Southern District of Texas under the antitrust laws. Specifically, FTC alleges that the defendants engaged in an anti-competitive scheme to consolidate ..read more

Duane Morris Takeaways: On Thursday September 14, 2023, the FTC issued a policy statement warning brand drug companies that improper listing of patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book” could violate Section 5 of the FTC Act. The Hatch-Waxman Act and FDA regulations outline ..read more

Continuing its implementation of the Modernization of Cosmetics Regulation Act’s (MoCRA), and following on the heels of FDA’s Draft Guidance on Facility Registration and Product Listing (previously discussed here), on September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product listings under newly added ..read more