Regulatory issues may wax and wane, but useful insights can surface along the way that may serve as guideposts for the regulated community.
The International Council on Harmonisation’s original Q9 guideline on risk assessment has drawn criticism over the years as too high-level and too open to variations in interpretation
Meanwhile, a journal article from a team of US Food and Drug Administration officials shows not only what the agency learned from its recent quality management maturity pilots, but also the message it received from industry when it polled a QMM workshop last year about the QMM program’s perceived benefits