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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
Lawmakers should consider requiring insulin manufacturers, PBMs and federal insurers’ drug plans to disclose their use of rebates, the caucus said. Read More
Commissioner Scott Gottlieb unveiled a redesigned FDA website on expanded access to clinical trials on Thursday and said the agency is “deeply committed” to helping critically ill patients with no other treatment options to join trials. Read More
The European Medicines Agency’s updated guidelines on good pharmacovigilance practices took effect Thursday — urging sponsors to pay particular attention to symptoms subjects may be unable to communicate. Read More
A Pennsylvania benefits fund filed suit against generic drugmaker Ranbaxy claiming it used its exclusive status to fraudulently block other generics for several drugs, including Nexium (esomeprazole), Diovan (valsartan) and Valcyte (valganciclovir). Read More