Regulatory Affairs Syndicator

Mandy Larsen of Beloit has a message for the federal Food and Drug Administration: Approve the vaccine against the sexually transmitted virus that can cause cervical cancer - and get it out to people fast.

The Food and Drug Administration is expected to approve a new vaccine that knocks out the virus that causes most cervical cancer cases by June 8. The question now, health experts say, is whether the public is ready to accept it.

Winston-Salem Journal - • NRG Energy Inc. up $6.73 at $49.74; Mirant Corp. down 37 cents at $24.88. Mirant said Tuesday that NRG refused its $57.50-a-share cash offer, which valued the electricity generator at $8 billion. • Royal Caribbean Cruises Ltd. up $2.39 at $38 …

As the Food and Drug Administration prepares to approve the first vaccine against infections that cause a majority of cervical cancers, religious conservatives are rallying to keep the vaccine from being mandatory for public school students.

In 2004, the FDA promulgated a regulation to require bar code identification on pharmaceutical labeling (FDA, 2004). While developing that regulation, FDA asked for public comment on whether such a regulation should be extended to medical devices. In…

Congress enacted the Mammography Quality Standards Act (MQSA) in 1992, marking the first time mammography facilities were required by the federal government to meet strict quality standards. The intent of MQSA is to assure the quality of mammography…

FDA is warning about a serious problem with Diastat AcuDial delivery systems, which are pre-filled syringes that contain diazepam. They’re designed to deliver the drug rectally to certain epilepsy patients with acute repetitive seizures, a condition…

FDA and CDC are alerting healthcare practitioners and contact lens wearers about an increasing number of reports of a rare but serious eye infection caused by the Fusarium fungus. The infection can cause significant vision loss and require corneal t…

Disetronic Medical Systems is recalling all ACCU-CHEK Ultraflex infusion sets, which are used with insulin pumps, because the set’s tubing could separate at the luer lock connection. This could cause a leakage of insulin, resulting in hyperglycemia….

Pfizer Pharmaceuticals has alerted healthcare professionals that severe allergic reactions have occurred in patients treated with Macugen. Macugen (pegaptanib sodium injection) is used to slow vision loss in people with the neovascular or ?wet? form…

FDA has received hundreds of reports of deaths and injuries in patients who became entrapped in hospital beds-sometimes through the bars of a side rail, or through the space between split side rails, or between the bed rail and the mattress, the head…

Based on recent reports of hepatotoxicity, the drug company Actelion has reminded healthcare professionals about the importance of monitoring liver function in patients receiving Tracleer (bosentan).

Tracleer is a limited-access drug that’s us…

A recent Institute for Safe Medication Practices safety alert warns about the danger of accidentally administering IV vincristine by the intrathecal route. ISMP cites a recent case where a syringe containing vincristine was accidentally delivered to…

A recent ISMP report, along with an advisory from the Pennsylvania Patient Safety Authority, points out the danger of misinterpreting the meaning of color-coded wristbands worn by patients. The confusion is often caused by certain colors having diff…

IMPORTANT NEW INFORMATION (June 5, 2006)

FDA notified healthcare professionals of the resumed marketing, with a special restricted distribution program of Tysabri (natalizumab), a monoclonal antibody for the treatment of patients with relapsing fo…