News & Analysis as of

Loper Bright Enterprises v Raimondo Administrative Procedure Act Pharmaceutical Industry

Mayer Brown

In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

Mayer Brown on

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges

As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more

Latham & Watkins LLP

New FDA Brief in Supreme Court Tobacco Case Puts Spotlight on Post-Chevron Regulatory Landscape

Latham & Watkins LLP on

FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

McDermott Will & Emery

Loper Bright and the 340B Statute

McDermott Will & Emery on

In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and...more

5 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide