The firings this week also include all staff responsible for managing records – such as new product applications – at FDA ...

As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT ...

More than 102 million U.S. households own a dog or a cat, and thousands more have fish, birds, or reptiles. The resulting pet ...

Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments ...

Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...

Federal efforts that have successfully driven down rates of youth vaping in recent years may be in peril after dramatic ...

The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...

The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.

Eli Lilly is escalating its legal push to protect the exclusivity of its high-profile weight-loss and diabetes drugs, ...

The Hatch Waxman Act and the Biological Price Competition and Innovation Act have incentivized efforts to improperly prolong ...

AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a ...

The U.S. Senate on Tuesday confirmed President Donald Trump's nominees Martin Makary and Jay Bhattacharya as heads of the ...