FDA recently doubled down on its approach of allowing new language in an ANDA label as the result of a section viii statement – a so-called “carve-in.” Section viii statements assert that an ANDA does not seek approval for...more
When the Federal Circuit resurrected Amarin’s “skinny label” infringement claims against Hikma last month, it offered some important lessons for drug developers. The precedential decision helps clarify the kinds of...more
For forty years, Chevron has put a thumb on the scales in favor of the executive agencies whenever their decisions were challenged in court. Now, the Supreme Court has overturned that longstanding precedent, issuing its...more
7/10/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more
Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable. Chevron U.S.A. Inc. v. Natural Resources Defense Council,...more
3/7/2024
/ Abbreviated New Drug Application (ANDA) ,
Chevron Deference ,
Chevron v NRDC ,
Drug Design ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
International Trade Commission (ITC) ,
Medicare Modernization Act ,
Nutritional Supplements ,
Prescription Drugs ,
SCOTUS
Yesterday, the Supreme Court heard oral arguments in two related cases that may have a significant impact on litigation against federal agencies – Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce....more
In the first decision to issue following the Supreme Court’s denial of certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, Magistrate Judge Sherry R. Fallon of the United States District Court for the...more