Harvard medical school professor Aaron Kesselheim resigns from the agencys Peripheral and Central Nervous System Drugs Advisory Committee, becoming th...
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.
FDA releases the FDA-483 issued following 2019 inspections of two trial investigators at the Hennepin County Medical Center.
Two members of the advisory committee that reviewed data and voted against approving Biogens Alzheimers therapy resign in protest over FDA irregularit...
FDA releases an FDA-483 with four observations from an inspection at the BSO outsourcing facility.
Federal Register notice: FDA sends to OMB an information collection extension for New Animal Drugs for Investigational Use 21 CFR Part 511 (OMB Contr...
Acer Therapeutics plans to submit an IND and protocol for a pivotal study of its Edsivo to treat patients with COL3A1+ vascular Ehlers-Danlos syndrome...