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whether it intends to only address animal studies assessing safety or if it is also targeting performance studies in a draft guidance from October.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.
Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.
The US agency made few changes in finalizing a 13 February guidance document on medical devices made to remove plaque from diseased arteries, but did incorporate manufacturer recommendations on corrosion testing and predicate comparisons.