Charging for expanded access drugs: FDA to let companies recoup their costs over time
The FDA on Monday updated guidance from 2016 on how companies can charge for investigational drugs under an IND, now telling sponsors working under expanded access that they can spread out their manufacturing, administrative or monitoring costs from the first year over the expected duration of the expanded IND or protocol.
The shift may ease the immediate cost burden for some smaller sponsors that have expensive bills to recoup.
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