US FDA Updates Online Device Export Tracker
The CDRH Export Certification and Tracking System will get a facelift on Sept. 26, with functionality changes to include a mandatory question on a company's most recent FDA inspection.
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A group of manufacturers and clinicians is asking the US agency to allow more discussion between manufacturers, labs and clinicians of how genetic factors could influence drug effectiveness – an area known as pharmacogenomics (PGx). The FDA had previously taken several steps to limit these communications.
The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.