Your search for ‘Hyman, Phelps, & McNamara’ returned 249 results

The fight between Jazz, Avadel, and FDA over narcolepsy drug sodium oxybate has been a long and arduous one. Starting in 2022 with a patent certification requirement...

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)...

For more than three decades, FDA has claimed that the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs)...

A few months ago, we blogged about a Texas U.S. District Court's Wulferic ruling that FDA's civil monetary penalty (CMP) provision for tobacco products contained...

You know a court decision is going to be worth reading when the judges compare FDA's regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting.

Last week, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) announced the introduction of two bills we've seen before: (1) S. 1096, the Preserve Access to Affordable Generics and Biosimilars Act.

On December 3, 2025, the U.S. Food and Drug Administration held its public meeting on the upcoming reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028–2032...

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...

Last Friday, October 31, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) Final Rule, which contained important changes...

With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985...

On December 16, CDRH issued 12 Warning Letters to manufacturers and retailers of breast binders.

On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDA's application and use of accelerated approval.

FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF).

The first anniversary is always special. Janus-like, it offers the opportunity to simultaneously reflect on hitting a milestone and projecting the future.

The Inflation Reduction Act (IRA) significantly changed the Part D benefit. As part of this change, the Coverage Gap Discount Program...

Much has changed since the long-gone days of 2017. The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu.

On January 6, 2026, FDA issued two revised guidance documents related to clinical decision support (CDS) software and low-risk general wellness products. In a video announcing the revised guidance documents...

Last Friday, the Delaware District Court rejected AstraZeneca's lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS's guidance implementing it.