FDA speeding generic drug approvals: not just lip service

RAPS

10 July 2017 - May and June 2017 have seen the most generic drug approvals since the US FDA began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs.

According to the activities report of the generic drug program, FDA approved and tentatively approved 96 generic drugs in May and 100 in June (a level FDA has not seen since December 2015 when 99 generics were approved and tentatively approved). May and June's numbers also compare to about 70 full and tentative approvals for the agency in the other months of 2017.

In addition, the number of complete response letters issued to the generic drug industry has been declining in 2017, from a high of 190 complete responses issued in March, to a low of 87 issued in June.

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Michael Wonder

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Michael Wonder