ROCKVILLE, MdStung by the failure of several researchers to
fully comply with federal gene therapy rules and reporting
procedures, the Food and Drug Administration (FDA) and the National
Institutes of Health (NIH) have taken a series of steps to tighten
the control and monitoring of such trials.
Most recently, the FDA announced that gene therapy researchers must
submit their clinical trial monitoring plans to the agency. FDA said
it will review the plans and seek changes to improve a programs
quality where needed. FDA will also conduct inspections of clinical
trials to assess whether researchers are following the monitoring
plans and whether monitoring has been adequate to identify and
correct critical problems.
FDA and NIH will also sponsor symposia about four times a year at
which gene therapy researchers will publicly discuss medical and
scientific data germane to their specialties and issues important to
the success and safety of clinical trials of gene therapy agents.