FDA News

FDA Plans IDs to Track Medical Device Safety

Medical devices like hip implants and heart defibrillators will soon join the ranks of cars and toasters. The U.S. Food and Drug Administration on Tuesday proposed a new rule that would require each medical device to have a unique code …

Regulators Urged to Monitor Safety Throughout Drug’s Lifecycle

The U.S. Food and Drug Administration should review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues, according to a report from an independent research body. The …

FDA Steps Up Scrutiny of Metal Hip Implants

The U.S. Food and Drug Administration responded to mounting concerns about the safety of metal-on-metal hip implants, saying it would subject the devices to a two-day expert review that could lead to rigorous new standards. The FDA announced on Thursday …

Herbal Sexual Enhancement Supplement Recalled

A Southern California firm is recalling an herbal female sexual enhancement supplement because it contains a drug not listed on the label. Irvine-based Regeneca said Saturday it will voluntarily pull RegenArouse after a Food and Drug Administration analysis confirmed the …

Breast Implant Scandal Shows Regulators in Dark on Tracking Risks

Long before the latest global breast implant scare, American health officials were toying with the idea of building a registry that would track patients with implants. The registry would give a better idea of the number of complications over time, …

Colorado Processing Plant Faulted in Listeria Outbreak

Unsanitary conditions at a packing plant that processed fresh cantaloupes from a Colorado farm likely contributed to one of the deadliest listeria outbreaks in U.S. history, health regulators said on Wednesday. The Food and Drug Administration said the design of …