Abbott Ushers Monkeypox Testing into Its New Commercial Phase
Abbott has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
Abbott has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
Abbott’s Alinity m MPXV assay for detecting DNA from the monkeypox virus received FDA EUA on Oct. 7.
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
The CDRH Total Product Life Cycle Advisory Program Pilot aims to improve the FDA authorization process for medical devices.
The new deal provides the FDA a minimum of $1.78 billion in user fees from 2023 to 2027.