This article was originally published in SRA
Industry and government launch reward scheme
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“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”
The yet-to-be-named medtech company will focus on orthopedic implants and bracing and recovery devices.
Our infographic offers a composite sketch from a decade of US FDA data on refuse-to-file letters.