Though they remain unpaid, hundreds of furloughed FDA employees will return to duty to conduct routine surveillance inspections of high-risk manufacturing facilities.

US FDA office that surveils drug manufacturing facilities invites sites on the cusp of failure for “engagements” in which they talk about how to turn things around. The agency says there’s no pressure – these site engagements aren’t enforcement actions and they’re completely voluntary.

Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.

Warren's proposed legislation aims to bring down prices and stabilize supplies by establishing government competition to generic drug monopolies.

Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.

Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.