Are compounders on notice? FDA may be coming for at least one of them, with a little help from its friends at the Justice Department. On the heels of the Novo Nordisk’s Wegovy® pill launch, Hims & Hers, in a headscratcher of a promotional move, doubled …
If Part 1 of our Rare Disease Month series highlighted The Good, and Part 2 addressed The Bad, Part 3 turns to The Ugly. And by “Ugly,’ we mean something entirely different – members of Hyman, Phelps & McNamara will be well represented at Rare …
February is Rare Disease Month, an important time to celebrate successes in addressing the needs of our fellow 25 to 30 million Americans living with a rare disease, but also to renew our resolve in addressing the much larger remaining challenges – both new and …
February is Rare Disease Month, designated as such to raise awareness and to support the millions of individuals affected by rare diseases. It is also an extremely meaningful time for those of us at HPM who work regularly with sponsors to help get therapies to …
FDA is now accepting submissions to its PreCheck Pilot Program, which is the Agency’s latest initiative to increase domestic production of pharmaceuticals. The two-phase structure of the Program and its benefits to industry, which we previously detailed in connection with the Onshoring Manufacturing of Drugs …
As prosecutions for manufacturing and distributing counterfeit drugs continue to rise with enhanced investigatory tools and federal statutes (see DEA’s recent announcement on “Operation Meltdown”), courts are grappling with how to fashion appropriate sentences. Last week, the Sixth Circuit Court of Appeals affirmed the 90-month …
As some of you know, tucked inside the Consolidated Appropriations Act of 2026, was some legislation that FDA has been pushing for quite some time. In addition to the incredibly important renewal of the Rare Pediatric Disease Priority Review Voucher program (blog on that forthcoming), …
On January 12th, FDA approved Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. Menkes disease is a rare, congenital X-linked genetic disorder characterized by impaired copper absorption, leading to severe copper deficiency, progressive neurologic deterioration, and death in early …
The American Conference Institute’s (“ACI”) FDA Boot Camp returns March 25-26, 2026, at the New York City Bar, New York, NY. This foundational training brings together life sciences attorneys, in-house counsel, and compliance professionals to dissect FDA law, policy, and enforcement trends. What You’ll Gain: A clear …
The skinny label has hit the big time. Last week, the Supreme Court agreed to hear Hikma v. Amarin to address the burning question of whether a carve-out induces infringement. As of now, the Federal Circuit has been very clear that a carve-out can induce …
Artificial Intelligence (“AI”) in the life sciences has moved from pilot to production, across discovery, trials, and post-market. With the EU AI Act taking effect, evolving FDA expectations, and looming litigation and enforcement risk, getting it right has never mattered more. Join the American Conference Institute …
Yesterday, FDA announced “Flexible Requirements for Cell and Gene Therapies to Advance Innovation.” This regulatory flexibility, FDA hopes, will be “helpful in expediting product development and will help guide the FDA’s evaluation of development strategies in preparation for a Biologics License Application (BLA) submission.” The announcement …
Yesterday, we posted Part I of our update on CMS’s proposed regulations to establish two most favored nation (MFN) demonstration models under Medicare Parts B and D, focusing on the Part D model, called Guarding U.S. Medicare Against Rising Drug Costs (GUARD). In this post, we …
In November, we posted that the New Year would be bringing us GENEROUS, a new Medicaid demonstration model initiated through CMS’s Center for Medicare and Medicaid Innovation (CMMI), which will permit drug manufacturers to enter into voluntary agreements with state Medicaid programs to provide most …
FDA wants to capitalize on the talent of venture capital (VC) firms that are developing innovative solutions that can be applied to FDA’s public health mission. On December 17, 2025, FDA issued a Request for Information (RFI) for its FIRE program, which stands for “Foundational …
