According to an article via BioPharmInternational.com, “A year-long process reauthorizing the Prescription Drug User Fee Act (PDUFA) was launched July 15, 2015 with a public meeting, setting the stage for monthly discussions with industry beginning this fall and...
In a new article via MassDevice.com, the Embargo Group said, “New draft guidance from the US Food and Drug Administration lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued...
According to FDANews.com, “Global drug regulators have reduced drug approval times over the last 10 years, and while the FDA remains the fastest at approving new drugs, other regulators are closing the gap.” For more information, visit: ...
Dr. Stefan Burde IVD Product Expert BSI GROUP Dr. Burde is an IVD Product Expert in the In Vitro Diagnostics Notified Body at BSI Healthcare. He joined BSI in 2014 as part of BSI’s expansion of the IVD team to address the growing need for Quality and Technical...
Andrea Miller Quality Assurance Director EPIC RESEARCH AND DIAGNOSTICS Ms. Miller has over 20 years of quality assurance experience in medical device manufacturing including positions at international device manufacturers such CR Bard, Inc. and DJO Global Inc....
