FDA's New Framework For Streamlining RMAT Reg Requirements Offers Clarity, But Some Questions Remain

One of FDA's newest regenerative medicine advanced therapies (RMAT) draft guidances provides the regenerative medicine industry with much-needed regulatory clarity and consistency, according to the head of lobby group Alliance for Regenerative Medicine (ARM), but some questions remain. The group's head said it will be interesting to see how FDA steps up enforcement in the space and predicts manufacturing and standardization questions will pop up. FDA will allow certain RMAT-device combinations to be classified as combination products, but in the...