RE:RE:FDA's Head of CBER wants faster approvals with SE/biomarkers
Another example of the FDA reversing / accelerating its approval process -
Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection
https://www.biospace.com/article/delcath-gets-fda-approval-for-melanoma-drug-device-combo-10-years-after-rejection/