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FDA permits marketing of the first hand-held device to aid


FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.

FDA collaboration to monitor rare eye condition associated with cataract


FDA collaboration to monitor rare eye condition associated with cataract surgery
The U.S. Food and Drug Administration and other government and professional organizations today unveiled a program to monitor medical devices used in cataract surgery in an effort to stem outbreaks of a rare, inflammatory condition associated with the procedure.
 
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FDA completes work on three drug user fee programs The


FDA completes work on three drug user fee programs
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.

 

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