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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
Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) announced a bill that would update what they say are outdated drug labeling standards. Read More
The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit from the EU, and said it will temporarily reduce or suspend more activities to save resources. Read More
The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements. Read More
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Read More
Drugmakers need to rethink the role of their quality departments, particularly when engaging with stakeholders and the broader company, says Marla Phillips, director of health initiatives at Xavier University, who previously served as head of quality at Merck’s North Carolina facility. Read More