Shaping A Shkreli Bill: Voucher Abuse Solution May Stumble On FDA Effects
House bill that would require new clinical studies from sponsor for tropical disease priority review vouchers met with industry concerns about limiting the US agency's flexibility.
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'Repeal And Replace' Going Relatively Well For Pharma So Far
US White House game plan for repealing and replacing the Affordable Care Act includes a proposal for faster generic drug approvals but no direct government price controls.
Bill To Speed ANDA Approvals Gets Cool Reception From Industry, US FDA
At House hearing, FDA and AAM highlight logistical challenges of legislation's six-month ANDA review goal and potential to put GDUFA II agreement at risk.
Rare Disease OPEN-ing In PDUFA Possible For Drug Repurposing Advocates
OPEN ACT would provide additional six months of exclusivity when existing drugs are approved for rare diseases; congressional debate over the measure could get bogged down in drug pricing issues.