MALLINCKRODT/MBI's FS069 PMA FOR ECHOCARDIOGRAPHY CLEARS FDA RADIOLOGICAL DEVICES ADVISORY PANEL; AGENCY ON TARGET TO MEET 180-DAY REVIEW DEADLINE
FDA's Radiological Devices Panel voted six to one to recommend approval of Molecular Biosystems' FS069 second-generation echocardiogram ultrasound contrast agent Feb. 24. FDA staffers say the agency is on target to meet its six-month deadline for a final decision on the PMA, which was submitted in October.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth