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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
The European Medicines Agency has begun a public consultation on revised module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans should focus on over a product’s lifecycle. Read More