The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco ...
RRAs are a mechanism for the FDA to conduct oversight of regulated entities without the need for on-site visits. RRAs were initially adopted during the COVID-19 pandemic to overcome travel ...
The FDA wants to know more about mobile-enabled clinical trials for investigational drugs. According to a recent post on the Federal Register by Associate Commissioner for Policy Leslie Kux, the FDA ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback