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The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
A string of proposed rules has been sitting on the FDA’s agenda for lengthy periods of time, sometimes for over a decade, and a recent accounting shows no signs of improvement. Read More
The FDA and other international regulators and law enforcement agencies have joined forces to crack down on illegal online drug distributors, requesting the suspension of 4,402 websites that sell illegal and potentially counterfeit products to U.S. consumers. Read More
An FDA advisory committee recommended the approval of Merck’s bezlotoxumab to prevent Clostridium difficile infection recurrence in patients 18 and older. Read More
In stark contrast to comments from generic industry trade groups, a patient advocacy organization is calling for including more information in biosimilar product labeling. Read More