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Four Democratic senators are calling for an investigation into a Native American tribe’s acquisition of four patents from Allergan, saying the deal is a “blatantly anti-competitive” scheme to avoid review of Allergan’s patents and to maintain its high prices. Read More
The FDA published a new manual of policies and procedures for reviewing staff, detailing how the agency will communicate ANDA deficiencies with applicants — meeting one of its first commitments for the next generation of GDUFA. Read More
The agency must adjust the incremental cost from fiscal 2016 by the average amount costs rose in the three years before the current fiscal year. Read More
An FDA advisory committee voted 10 to 1 Wednesday that a muscular dystrophy drug candidate does not have enough supporting data to be considered effective. Read More