We reported in August that CMS proposed to rescind the Most Favored Nation (MFN) drug pricing interim final rule issued in the latter days of the Trump regime. Today, CMS finalized that proposal, effectively putting an end to the concept of international reference pricing as …
Since California passed AB 824: Preserving Access to Affordable Drugs in September 2019, the Association for Accessible Medicines (“AAM”) has been trying to invalidate the law, which imposes a presumption of anticompetitive effect on any Paragraph IV patent settlement in which the generic sponsor receives …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Adrienne Lenz will be speaking on Deciphering New and Proposed Regulatory Guidances For Medical Devices and Diagnostics at the Q1 Productions 4th Annual Life Science Regulatory Intelligence Virtual Event being held January 24-25, 2022. The …
On December 7, 2021, the Natural Products Association (NPA) filed a complaint seeking an injunction based on FDA’s actions excluding N-acetyl-L-cysteine (NAC) from the definition of dietary supplement. At issue is FDA’s interpretation of the “exclusionary clause,” section 201(ff)(3)(B)(ii) of the FDC Act, which among …
On December 6, 2021, FDA published a proposed rule to reorganize and amend the highly criticized agricultural water provisions of the Produce Safety Rule (PSR). This marks the Agency’s latest effort to balance public health protections with covered farms’ persistent concerns that the current provisions …
It seems like every other discussion I have these days someone asks, “what is going on with the pre-submission program?” “I heard CDRH isn’t reviewing pre-submission,” or “I heard FDA is only providing written feedback and not holding meetings.” So, we thought it was time …
Nothing says “happy holidays” quite like the issuance of Federal Trade Commission (FTC) orders – essentially, subpoenas – to large retailers, wholesalers and suppliers of food, cosmetics, personal care and OTC products, among other things, during the supply chain’s busiest time of the year. Antitrust …
Hyman, Phelps & McNamara, P.C.’s Anne Walsh will be moderating “Updates in Litigation Risks: Product Liability, Private Litigation, and Consumer Class Actions,” at the upcoming Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10. As we move out of the COVID-19 …
Earlier this fall, in accordance with its MDUFA IV commitments, CDRH launched an online platform that allows sponsors to track the status of its submissions. The platform is called the Customer Collaboration Portal (CCP) and is “a secure, web-based tracker that displays the CDRH progress …
