FDA General
<ѻýҕl>FDA Panel Puts Brakes on Anti-PARP Drugѻýҕl>
WASHINGTON -- Approval of a PARP inhibitor for patients with advanced ovarian cancer should await results of an ongoing clinical trial that has the potential to answer questions about the drug's safety and efficacy, according to an FDA advisory committee that voted against immediate approval.
Jun 25, 2014
<ѻýҕl>Medtronic's Infuse Moves From Operating Room to Courtroomѻýҕl>
An investigative series by ѻýҕl/Milwaukee Journal Sentinel has been tracking the spinal fusion device called Infuse in a 4-year-long series and now reports how a flawed FDA system for device approval may have led to a long string of adverse events culminating in thousands of liability suits.
May 18, 2014
<ѻýҕl>FDA Slashes Starting Dose for Lunestaѻýҕl>
SILVER SPRING, Md. -- Patients starting on the sleep drug eszopiclone (Lunesta) should take no more than 1 mg at bedtime -- one-third the current label-recommended dose -- because of the risk of next-day impairment, the FDA said Thursday.
May 15, 2014
<ѻýҕl>Droxidopa for OH Slammed by FDA Reviewersѻýҕl>
SILVER SPRING, Md. -- Droxidopa (Northera) is getting a second look by an FDA advisory committee for the treatment of orthostatic hypotension stemming from neurological disorders like Parkinson's disease, but an agency review doesn't look promising for approval.
Jan 13, 2014
<ѻýҕl>Killing Pain: Tramadol the 'Safe' Drug of Abuseѻýҕl>
Almost 2 decades have passed since the FDA approved tramadol as a 'safe' opioid, but the intervening years provide evidence to question that 'safe' claim, as this latest investigation by John Fauber for the Milwaukee Journal Sentinel-ѻýҕl revealed.
Dec 22, 2013