Regulatory Affairs Syndicator

The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. …

FDA recently alerted health care providers that treatment of children and adolescents with Strattera increases the risk of suicidal thinking. Strattera (atomoxetine) is approved to treat ADHD in patients 6 years and older. The increased risk of …

FDA recently issued Public Health Notification about serious adverse events, including death, occurring with Enteryx, a product made by Boston Scientific that's used to treat gastroesophageal reflux disease (GERD). Enteryx is a liquid copolymer that…

FDA and CDC are alerting health care providers and consumers about six reports of Guillain-Barre Syndrome following administration of Menactra, a Meningococcal vaccine manufactured by Sanofi Pasteur. At this point, it isn't known whether these …

GlaxoSmithKline has notified healthcare professionals that new precautionary information is being added to the labeling for the antidepressant Paxil (paroxetine hydrochloride).The new information summarizes a retrospective epidemiologic study per…

ISMP recently issued a Safety Alert called "Paralyzed by Mistakes," which warned about inadvertently giving neuromuscular blocking agents such as pancuronium to patients who aren't receiving ventilator support. This can lead to respiratory arrest. …

Luer fittings, connectors, and locks are small, inexpensive, and convenient. They're commonly used to connect many medical devices, components, and accessories. Unfortunately, because they're so easy to use, health care personnel may mistakenly conn…

Medication errors can sometimes occur when drug names look or sound alike. For example, FDA has received reports of mix-ups between several drugs that all begin with the letter "T": Toprol-XL, a beta-blocker, Topamax, which is used to treat epileps…

GlaxoSmithKline has notified healthcare professionals that new precautionary information is being added to the labeling for the antidepressant Paxil (paroxetine hydrochloride).The new information summarizes a retrospective epidemiologic study per…

ISMP recently issued a Safety Alert called "Paralyzed by Mistakes," which warned about inadvertently giving neuromuscular blocking agents such as pancuronium to patients who aren't receiving ventilator support. This can lead to respiratory arrest. …

HIV test may lead to a new sexual trendTaipei Times, Taiwan - 5 hours ago… drug advisory committee last month, OraSure Technologies in Bethlehem, Pennsylvania, is expected to apply to the US Food and Drug Administration soon for …

HIV test may lead to a new sexual trendTaipei Times, Taiwan - 3 hours ago… drug advisory committee last month, OraSure Technologies in Bethlehem, Pennsylvania, is expected to apply to the US Food and Drug Administration soon for …

HIV test may lead to a new sexual trendTaipei Times, Taiwan - 8 hours ago… drug advisory committee last month, OraSure Technologies in Bethlehem, Pennsylvania, is expected to apply to the US Food and Drug Administration soon for … what i…

Regulations / Law China’s State Food and Drug Administration has recently issued new rules regarding the management of record filing for accepting foreign orders for drug process on a commissioned basis, which will come into effect as of January 1, 2006.

China’s State Food and Drug Administration has recently issued new rules regarding the management of record filing for accepting foreign orders for drug process on a commissioned basis, which will come into effect as of January 1, 2006.