The agency will look for medical device-related safety issues reported in EHRs, billing claims and pharmacy data, according to a U.S. Government Accountability Office report released Aug. 15. The ...

This course highlights the requirements and importance of an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe.

FDA Building 21 stands behind the sign at the campus's main entrance and houses the Center for Drug Evaluation and Research. The FDA campus is located at 10903 New Hampshire Ave., Silver Spring, MD ...

A chronic hepatitis B surveillance and management program can be beneficial to patients. Kaiser Permanente Northern California’s (KPNC) systematic surveillance and management program for chronic ...