Auto-Injector Issues Get Cross-Center Investigation From US FDA
Reports of bent needles and injector failures in auto-injectors filled with generics of multiple sclerosis drug Copaxone also raise questions about the FDA’s complex product approval process.
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Advisory committee members say clinical data proves the second shot should be considered part of the primary series, while Janssen wants it called a single-shot vaccine with a booster.
Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.
Agency assessors couldn’t independently verify several Janssen analyses of booster shot data and raised concerns about small samples sizes and an unvalidated immunogenicity assay.