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Senate Majority Leader Mitch McConnell (R-Ky.) said the FDA user fee reauthorization will be voted on before the Senate adjourns for its summer recess, scheduled to begin Aug. 14. Read More
Intellipharmaceutics artificially inflated its stock prices during the NDA process for its oxycodone product Rexista, a new class-action lawsuit claims. Read More
A third-party evaluator should be used to assess the expanded communications program proposed in the next generation of the FDA’s biosimilar user fees, according to BIO. Read More
As part of the Trump administration’s deregulatory push, the FDA has withdrawn nine planned regulations for the pharmaceutical industry, some in the works for years. Read More
A White House commission on opioid abuse, established in March by executive order, delivered its initial set of recommendations to President Trump, urging him to declare an immediate, national state of emergency. Read More