RT Journal Article
SR Electronic
T1 FDA’s Biomedical Research Program
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 134
OP 138
VO 34
IS 2
A1 Kelsey, Frances O.
YR 1980
UL http://journal.pda.org/content/34/2/134.abstract
AB The agency-wide Bioresearch Monitoring Program was initiated in 1977. Its goals are to ensure the integrity of preclinical and clinical data submitted in support of applications for approval of agency-regulated products and to assure that subjects of clinical tests are not exposed to unnecessary risks. An update of the educational and regulatory actirities under this program will be presented and pertinent findings of surveillance and compliance inspections of non-clinical laboratories, sponsors and monitors. and institutional reicew boards will be described and discussed.