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.
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Millennium Pharmaceuticals Ninlaro (ixazom...
Federal Register notice: FDA reopens the comment period for a 9/26/2017 notice on a potential approach for device sponsors who seek to obtain marketin...
FDA staff return to work Tuesday (1/23) after the U.S. Senate reaches an agreement to pass a continuing resolution that will end the current three-day...