FDA Approvals - Acusphere Submits New Drug Application for FDA Approval of Imagify(TM)
Acusphere Submits New Drug Application for FDA Approval of Imagify(TM) (Business Wire via Yahoo! Finance)
WATERTOWN, Mass.----Acusphere Inc. announced today the submission of a New Drug Application to the U.S. Food & Drug Administration for approval to market its lead product candidate, Imagify .
FDA Official Says Agency Cannot Ensure Safety Of All Medications Sold In U.S. (Medical News Today)
Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, on Thursday at a Senate hearing said that the number of medication ingredients manufactured abroad limits the ability of the agency to ensure the safety of all treatments sold in the U.S., CQ HealthBeat reports (Carey, CQ HealthBeat, 4/24).