FDA releases an FDA-483 with three observations issued following an inspection at AnazaoHealth.
The International Council on Harmonization reelects FDAer Theresa Mullin to a one-year term as chair of its management committee.
FDA warns American Contract Systems about Quality System violations in its work manufacturing medical devices and acting as a contract sterilizer.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Amgens Aimovig (erenumab-aooe).
Senate Health, Education, Labor & Pensions Committee votes 18 to 5 to advance Stephen Hahns nomination to serve as FDA commissioner to the full Senate...
Federal Register notice: FDA makes available a final guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics.
Five bipartisan members of Congress ask HHS and CMS to include unique device identifiers on health insurance claims forms to enhance post-market surve...
FDA releases the FDA-483 with three observations from an inspection at Nubratori, Inc.