The FDA is approving generic drugs faster than ever. But what’s driving the increase in approval speed, and what does it mean for the pharmaceutical industry?
HRI also found:
Cumulatively, changes made by the FDA have resulted in substantial benefits for the generics industry, including faster approvals, new exclusivity, new staff with which to review applications and new guidance documents. A comparison by HRI of the last five years shows just how substantial those changes have been.
As the full effects – and funding – of FDARA come into effect, the FDA is likely to continue to approve record or near-record numbers of generic drugs.
To read more about how the FDA is speeding up generic drug approvals and what it means for the pharmaceutical industry, please read HRI's report, Is new generic competition enough to lower drug costs?