www.fdanews.com/articles/113731-cber-meets-fast-track-designation-deadlines-most-of-the-time
CBER Meets Fast-Track Designation Deadlines Most of the Time
January 14, 2009
CBER, which received more than 200 fast-track designation requests over the past 10 years, made decisions on the applications within the statutory 60-day deadline 98 percent of the time. CBER acted within two months on 202 of the 207 requests it received between March 1, 1998, and Dec. 31, 2008, according to a statement posted on the FDA’s website. Only five decisions on requests were delayed until after the deadline, with one request pending.
Drug Industry Daily
Drug Industry Daily