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Some nations may be consuming too many antibiotics that the World Health Organization has determined must be reserved for emergencies to limit antibiotic resistance. Read More
The FDA hit back at Teva’s lawsuit accusing the agency of changing its policy on granting 180-day exclusivity for generics — arguing that the company’s attempt to block exclusivity for competing Restasis (cyclosporine) generics was “built atop a tottering tower of conjecture.” Read More
The agency said its website has seen a steady increase in traffic over the last three years compared to relatively stagnant activity on mobile devices. Read More
Two prominent UK drug organizations say they’re “generally supportive” of MHRA’s contingency plans if the UK exits the EU on March 29 without a deal, but expressed concern about orphan drugs and centrally authorized product licenses, among other issues. Read More
A federal lawsuit filed in Massachusetts claims Indian generic drugmaker Hetero and its U.S. subsidiary Camber Pharmaceuticals ignored warning signs that the blood-pressure drug valsartan was contaminated and continued to supply it in the United States. Read More
Sens. Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) appealed directly to the White House Thursday for help passing legislation that would ban pay-for-delay deals between drugmakers. Read More
The FDA is streamlining its reporting of inspections for sterile injectable drugs to help make risk-based regulatory decisions, Commissioner Scott Gottlieb announced Friday. Read More