RT Journal
A1 Mitka M
T1 ANtibiotic pipeline
JF JAMA
JO JAMA
YR 2012
FD April 11
VO 307
IS 14
SP 1476
OP 1476
DO 10.1001/jama.2012.414
UL http://dx.doi.org/10.1001/jama.2012.414
AB 
The IDSA submitted its proposal to the House Energy and Commerce Committee's Subcommittee on Health during a March 8 hearing on reauthorizing the Food and Drug Administration Prescription Drug User Fee Act. The proposed new approval pathway, called the Special Population Limited Medical Use mechanism, would enable pharmaceutical companies to study designated drugs—intended for targeted use within a special population of patients who lack other treatment options—in far fewer patients than currently required, more rapidly, and at significantly less cost.