FDA is the first to acknowledge that a lot of things went wrong during the run-up to the prasugrel advisory committee meeting, not the least of which is how the agency handles allegations of intellectual bias among its members. For drug sponsors, it may mean that the rules of engagement have changed.
by Kate Rawson
In the eyes of critics of the Food & Drug Administration, a lot of things went wrong during the advisory...
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Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.
While challenges in the US present an “incredible opportunity” for Europe, there is no “doomsday” happening there, Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
