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.

FDA and industry have serious concerns with a proposed six-month priority review pathway for generic drugs offered in recent legislation, arguing it may not actually get generics to market faster.

Both industry and agency agree with the bill's ultimate goal, pushing more generic competition to the market faster. But during...

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