TY  - JOUR
T1  - SPeeding drug approvals
AU  - Mitka M
Y1  - 2012/05/09
N1  - 10.1001/jama.2012.4001
JO  - JAMA
SP  - 1904
EP  - 1904
VL  - 307
IS  - 18
N2  - 
The bill would amend the Food, Drug, and Cosmetic Act to require the FDA to facilitate the development and expedite the review of breakthrough drugs. These are defined as medications that are intended for a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that these medications may demonstrate substantial improvement over existing therapies.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2012.4001
UR  - http://dx.doi.org/10.1001/jama.2012.4001
ER  -