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The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Read More
The European Medicines Agency is implementing a new form to submit required postmarket data on safety, efficacy and quality, and it is now a mandatory part of Module 1.0 of the electronic common technical document format. Read More
The FDA directed a Canadian opioid manufacturer to send information to doctors correcting the complete absence of warnings of serious risks associated with the drug in professional promotional materials distributed earlier. Read More
BIO and PhRMA filed a lawsuit challenging Nevada’s new price transparency law for diabetes drugs, arguing it oversteps the state’s authority. Read More
Carlton’s Dunwoody Pharmacy failed to establish a testing program, failed to prepare production records, used inadequate instruments, and violated labeling rules. Read More
Two AIDS patient advocacy groups urged New York Attorney General Eric Schneiderman — a frequent foe of anticompetitive behavior by drugmakers — to investigate potential pay-for-delay deals by Gilead. Read More