FDA, CMS Indefinitely Extend Parallel Review; Industry Response Muted

FDA and CMS will indefinitely extend their parallel review program for medical devices, the agencies announced Friday (Oct. 21). The program was subject to much industry scrutiny when introduced in 2010, but a key device trade group indicated it now supports the effort. The agencies said in 2011 that they intended to expand the program to drugs and biologics, which trade groups had previously urged against, but the proposed drug and biologic pilots have not yet moved forward. The parallel...