RT Journal
A1 Klein DF
T1 THe report by the institute of medicine and postmarketing surveillance
JF Archives of General Psychiatry
JO Archives of General Psychiatry
YR 1999
FD April 1
VO 56
IS 4
SP 353
OP 354
DO 10.1001/archpsyc.56.4.353
UL http://dx.doi.org/10.1001/archpsyc.56.4.353
AB 
The charge to the IOM goes beyond the usual concerns of the FDA about the adequacy of the pivotal clinical trials in a request for drug approval. The FDA further wishes the IOM to comment on the quality and quantity of postmarketing data, confidence in data on the effectiveness and adverse effects of Halcion at different doses and for different durations, and the need for additional studies.