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FDA approved more generics in July than any previous month

Published on 10/08/18 at 10:18am

FDA Commissioner Scott Gottlieb took to Twitter to announce the news that the FDA smashed its previous record for number of generic drug approvals in a single month, authorising a total of 126 such medications throughout July this year.

The total figure breaks down into 96 approvals of generic products alongside a further 30 tentative approvals. Gottlieb tweeted to his followers to celebrate the achievement:

“GENERIC DRUG NEWS: #FDA beat another record. July saw the highest number of approval actions in the history of the generic drugs program in a single month with 126 total approvals (96 full approvals + 30 tentative approvals)”

Prior to the introduction of a user fee programme in 2012, the FDA had a backlog of more than 10,000 applications to work through; now, the agency receives money for each application, allowing them to use those funds to improve operational efficiency. Republicans and the Trump administration have been pushing to bring down approval times, and this latest record suggests these attempts are paying off; the agency now attempts to review all drug applications within a window of 10 months

Matt Fellows

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