FDA clears a Nuvo Group 510(k) for its InVu remote pregnancy monitoring platform that adds a new uterine activity module for remote monitoring.
An Eli Lilly investigation into whether a company executive altered manufacturing documents required by FDA finds no wrongdoing.
Federal Register notice: FDA sends to OMB an information collection extension for a Class 2 special controls guidance on blood cell separator devices...
The CDER Office of Prescription Drug Promotion solicits public comment on two proposed studies to examine accelerated approval disclosures on direct-t...
FDA approves an expanded indication for Avita Medicals Recell thermal burn treatment system.
FDA says the public should not use the Innova SARS-CoV-2 antigen rapid qualitative test that has been recalled by the company for potential false posi...
Federal Register notice: FDA makes available a draft guidance entitled Core Patient-Reported Outcomes in Cancer Clinical Trials.
FDA extends from 3 to 4.5 months the approved storage time for the Johnson & Johnson Covid vaccine.