US FDA introduces tropical disease priority review fee for FY 2011
This article was originally published in SRA
Executive Summary
Drugs and biologics companies looking to knock four months off the review period of their tropical disease product applications by using special priority review vouchers will have to pay a fee of about $4.6 million to the US Food and Drug Administration in fiscal year 2011. While a standard review spans a ten-month period, the use of the voucher would ensure that the review process is completed within six months1.