FDA 'Intercenter Institutes' Legislation Headed For Senate Mark-Up

28 Mar 2016

• By Michael McCaughan and Kate Rawson

FDA would be directed to test the concept of joint drug/device/diagnostic reviews in at least one therapeutic area; idea of further integrating medical product reviews is also part of Vice President’s cancer 'moonshot.'

The Senate Health Committee has unveiled formal legislative language to direct FDA to test consolidated medical product reviews in at least one disease area.

The legislation would direct FDA to create “Intercenter Institutes” focused on specific disease areas. Each Institute would “develop and implement...