QUOTED. 1 July 2021. Howard Chazin.
Executive Summary
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, FDA official Howard Chazin said at a recent conference.
“We are talking with our colleagues over at CDRH to let them become more aware of this happening and having internal meetings and coming up with plans to see if this is just an isolated incident or if there’s a broader cross-communication we can have to sort of just proactively attend to this kind of issue." – Howard Chazin, director, clinical surveillance staff, Office of Generic Drugs, Center for Drug Evaluation and Research, US FDA
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