RT Journal A1 Mitka M T1 SPeeding drug approvals JF JAMA JO JAMA YR 2012 FD May 9 VO 307 IS 18 SP 1904 OP 1904 DO 10.1001/jama.2012.4001 UL http://dx.doi.org/10.1001/jama.2012.4001 AB 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.