FDA clears a Techlab 510(k) for the Campylobacter Quik Chek and the Campylobacter Chek tests to aid diagnosis of campylobacteriosis.
FDA releases its latest batch of Warning Letters that includes BBCOS, Beauty Manufacturing Solutions, BioModeling Solutions and Wong Lap Kwong Medicin...
CDERs Office of Prescription Drug Promotion issues a notice of violation to UCLA over promotional materials for an unapproved investigational new drug...
FDA issues a white paper with key considerations for creating a Quality Overall Summary that is useful to regulators.
CBER issues a list of nine guidance documents it plans to develop in 2018.
FDA commissioner Scott Gottlieb says he is trying to learn from mistakes made by FDA in the past in dealing with the opioid crisis.
To address ongoing critical product shortages, FDA approves shelf life extensions on certain Baxter Healthcare intravenous solutions that are in short...
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Ardea Biosciences Zurampic (lesinurad) was...