News

National Law Review10h
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...
JD Supra11h
Regulation, Enforcement, and Associated Challenges of the ENDS Industry: Part I
In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine ...
STAT7d
FDA cuts may mean even less oversight of pet food
More than 102 million U.S. households own a dog or a cat, and thousands more have fish, birds, or reptiles. The resulting pet ...
JD Supra1d
District Court Embraces Loper Bright and Overturns FDA Laboratory Developed Test Rule – What Lies Ahead?
Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in ...
Opinion
Food Safety News10dOpinion
New priorities require resources, expertise, and regulations: Where will they come from?
By Steven Grossman Secretary Kennedy’s announcement came last Thursday: FDA’s contribution to the pending HHS reduction in force (RIF) would ...
Fierce Pharma9d
For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty
The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...