Is Bloom Gone From Rosy ANDA Approvals Figures?
US FDA sets a new monthly record for full approvals, but industry group argues that approvals alone aren't creating more generic competition in the market.
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With US House of Representatives now controlled by Democrats, lower chamber of Congress will likely increase hearings and investigations into industry pricing practices, but any legislation will likely need to dovetail with President Trump’s agenda to advance.
US FDA also refused to receive many priority generic drug applications, suggesting the expedited pathway may not be working as intended quite yet.
FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition.