More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological ... around manufacturing quality and strengthening post-market surveillance initiatives as outlined in the CDRH ...

Sitting before senators at his confirmation hearing to become commissioner of the FDA, Johns Hopkins surgeon and author ...

Groundbreaking technology from PeraHealth that monitors patient health and flags up anomalies has been given the green light by the Food and Drug Administration (FDA). PeraTrend is the first ...

An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections ... U.S. and ...

Generic names are assigned by international organizations, such as the U.S. Adopted Names (USAN) Council, the Food and Drug Administration (FDA ... and other post-marketing surveillance.

Perakslis is a medical and privacy researcher and has served in the FDA. Stebbins is a health and ... companies are calling for changes in drug regulation and the costs of medicines.

DCGI has sought post-market surveillance data from the drugmakers of two fixed-dose combination medicines—Imipramine Hydrochloride IP + Diazepam IP tablets used to ease co-morbid anxiety, and ...

a step that could spell the end to a booming market of cheap, pharmacy-made weight-loss drugs that has attracted a huge patient following. The FDA said it will give compounding pharmacies until ...

Pharmaceutical giants that market lucrative weight-loss drugs have battled with firms that sell less expensive versions made by compounding pharmacies. The FDA allows compounding pharmacies to ...

At the same time, the company he founded, Roivant Sciences, is pursuing studies for three drugs that, if positive, could land before the FDA during ... emphasis on post-approval surveillance ...