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Drugmakers submitting anonymous clinical data in applications to the EMA must keep up on technology advances that could put that data at risk for re-identification. Read More
The FDA’s regulations for drug promotions desperately need to be updated as they are unlikely to survive future court challenges, industry experts say. Read More
Newly confirmed FDA Commissioner Robert Califf sought to quell concerns about the FDA’s response to the opioid epidemic at a Senate hearing on the FDA’s $5.1 billion budget request for fiscal 2017. Read More
The U.S. Attorney’s Office for the Southern District of New York issued a subpoena to Horizon requesting information related to its patient assistance programs, the drugmaker disclosed in an SEC filing. Read More