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The FDA updated its guidance on communications with generics manufacturers to reflect the timelines agreed to in the second generation of the GDUFA program, which took effect Oct. 1. Read More
The U.K.’s National Institute for Health and Care Excellence published guidances for three drugs in four indications, recommending their use by the NHS as long as the sponsors comply with patient access programs and agreed-upon discounts. Read More
A worker benefits fund filed a lawsuit against Johnson & Johnson this week for allegedly maintaining an illegal monopoly for its Crohn’s disease drug Remicade. Read More
The European Medicines Agency is already changing its procedures in advance of the UK’s departure from the European Union in 2019, with the pending withdrawal affecting which experts the agency appoints to investigate applications for new drug approvals, the agency said. Read More
Two Endo International subsidiaries sued the FDA last week to have the agency’s bulk drug compounding decree on compounding operations declared illegal and to halt compounding involving the API vasopressin. Read More