News Focus
News Focus
Replies to #62566 on Biotech Values
icon url

DewDiligence

05/13/08 10:26 AM

#62571 RE: tinkershaw #62566

>VRTX – Would this not be a Reg-E filing?<

Subpart-E accelerated approval applies only to biologics; for small-molecule drugs such as Telaprevir, the corresponding FDA reg is Subpart H. The basic idea is the same, however.