Citing potential for supply disruptions to patient care, the Healthcare Distribution Alliance (HDA) has recommended a phased approach to the FDA's final implementation of the Drug Supply Chain Security Act…
Unauthorized sharing of users’ health data with several third parties — including Google — has gotten fertility app developer Easy Healthcare a $100,000 fine and a federal court order to…
Multiple clinical trial results from two manufacturers posted in the past several days in The Lancet show high levels of success of both weight loss in obese adults and in…
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily
Two years after its repeal of a rule that would have expedited Medicare coverage for FDA-cleared Breakthrough Devices, CMA Thursday issued a request for comment on a process to provide…
The U.S. government filed an appeal of a jury’s recent decision in the CDC patent infringement case involving Gilead’s HIV-prevention regimen, seeking $1 billion in compensation against Gilead’s $10 billion…
The Orphan Drug Act should give Jazz Pharmaceuticals the full seven years of exclusivity for its blockbuster narcolepsy drug, Xywav, says Jazz in its suit against the FDA, claiming the…
Addressing growing interest in the therapeutic potential of psychedelic drugs, the FDA has published a draft guidance noting multiple unique considerations for psychedelic drug development programs and challenges in designing…
The FTC has filed an amicus brief urging a U.S. appeals court to side with the plaintiffs in a case that alleges Forest Laboratories paid several generics producers millions of…
PhRMA joined the constitutional showdown over the Inflation Reduction Act (IRA) by filing a complaint on Wednesday in the U.S. District Court for the Western District of Texas. Source: Drug…