FDA releases the form FDA-483 with five observations from an inspection at the Torrent Pharmaceuticals facility in Indrad, Gujarat, India.
FDA grants a de novo marketing authorization to Cepheid for its Xpert HCV test and GeneXpert Xpress System for detecting hepatitis C virus.
FDA publishes a guidance to help sponsors pursue Priority Zoonotic Animal Drug designation for a new animal drug.
FDA publishes a draft guidance on the content and format of certain diversity action plans intended to increase clinical study enrollment of participa...
FDA approves a Verona Pharma NDA for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult p...
BrainStorm Cell Therapeutics says it has reached alignment with FDA on chemistry, manufacturing, and controls aspects of the companys upcoming Phase 3...
CDRH says it is partnering with the Bill and Melinda Gates Foundation and the National Institute for Standards and Technology on a project to develop ...
Federal Register notice: FDA submits to OMB a proposed information collection entitled Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP...
