The US Food and Drug Administration (FDA) says it intends to ban electrical stimulation devices (ESDs) used to treat aggressive and self-injurious behaviors after an advisory panel recommended banning the devices in 2014. According to FDA, ESDs are only used to treat aggressive and self-injurious behaviors at a single US facility, the Judge Rotenberg Educational Center in Canton, MA. FDA proposed the ban in a notice appearing in the Federal Register on Friday, saying ...

The US Food and Drug Administration (FDA) on Monday announced its intent to ban the use of most powdered medical gloves, citing an "unreasonable and substantial risk" to patient health. "This ban is about protecting patients and health care professionals from a danger they might not even be aware of," said Jeffrey Shuren, director of the Center for Devices and Radiological Health. The proposed ban would apply to all powdered surgeon's gloves, powdered patient examinatio...

Four executives once associated with bone product and medical device manufacturer Synthes will be barred from participating in any federal healthcare program after serving prison time for what prosecutors said was a disregard for patient safety, federal health officials have announced. The four-Michael Huggins, formerly COO; John Walsh, director of regulatory affairs; Thomas Higgins, president of Synthes' spine division; and Richard Bohner, VP of operations-were sente...

Two doctors are on the receiving end of debarment orders issued by the US Food and Drug Administration (FDA) after the agency found both to have injected patients with an unapproved and illegally obtained version of Botox (botulinum toxin) in violation of the Federal Food, Drug and Cosmetic Act (FDCA) . The two had separately obtained illicit versions of Botox-commonly used as a cosmetic agent to reduce wrinkles-from Toxin Research International, Inc (TRI). The first, ...

The US Food and Drug Administration (FDA) is announcing changes to its rules governing how clinical investigators are disqualified, vastly expanding the scope of the disqualification. Under existing rules, if FDA determined a clinical investigator has broken rules such that the agency disqualifies them from conducting clinical investigations on one type of test article (e.g. drugs), they may still be allowed to investigate other, non-related products (e.g. medical device...

The US Food and Drug Administration (FDA) took the "rare step" to disbar four quality control professionals formerly employed by the now-defunct genomics company Able Laboratories, reports Fierce Pharma Manufacturing and Pharmalot . According to The Federal Register the four are banned from "providing services in any capacity to a person that has an approved or pending drug product application," effectively severing them from the pharmaceutical industry. Companies f...