Amarin and FDA explore settlement of Vascepa suit. The agency could allow Amarin to proceed with its statements and disclosures rather than risk a difficult appeal to the Second Circuit, the same court that handed FDA a loss in Caronia three years ago.
FDA's exploration of a legal settlement with Amarin Corp. PLC involving statements about off-label use of Vascepa (icosapent ethyl) suggests the agency is not interested in appealing an adverse First Amendment ruling in the case to the Second Circuit US Court of Appeals.
Instead of making what experts predict would be a highly challenging appeal to the Second Circuit, FDA may have decided...
The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.
Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.
