Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment Registration and Product Listing for Manufacturer...
FDA allows Johnson & Johnson (Janssen) to use two batches, but not others, of its Covid-19 vaccine substance made at Emergent BioSolutions troubled co...
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.