The regulatory agency’s current timeline for the approval or rejection of new drugs is currently 10 months, or six months for a priority review.
But as part of a new proposed deal with the prescription drug industry – regarding fees for drug reviews – the board now says it will need an extra two-month “filing date” before the process can begin.
However the new five-year agreement will do little to appease congressional republicans, who have recently slated the industry for having a lengthy approval procedure.