We all evaluate risks on a daily basis, ranging from simple ones (such as stepping on the gas when a yellow
light is about to turn red) to more serious considerations (such as leaving a stable white-collar job to start a
restaurant business).
As far as the FDA is concerned, its risk-based method is designed to maximize public health protection. The agency
must match the level of its review and inspection efforts to the magnitude of a risk. The fact is, federal resources are
limited and it’s impossible to expect a uniformly intensive coverage of all pharmaceutical products and manufacturing
processes. The agency has been implementing risk-based programs, but it says there’s a need for a more systematic and
rigorous risk-based approach.
