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whether it intends to only address animal studies assessing safety or if it is also targeting performance studies in a draft guidance from October.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.
The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.
Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.