J&J Pledges To Stop Animal Use In Sales Training
The manufacturer was facing PETA protests in response to a leaked plan to allow pigs to die as part of sales-rep training later this month.
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Industry and regulatory groups say FDA should make it clearer in a final guidance whether it intends to only address animal studies assessing safety or if it is also targeting performance studies in a draft guidance from October. There are also questions about reporting of raw data from animal studies, and PETA weighs in.
Three patients have filed suit against Medtronic in recent weeks alleging they were injured by malfunctioning surgical staplers made by the company. The lawsuits add to recent scrutiny of the device type’s safety.
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.