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FDA publishes a draft guidance on the content and format of certain diversity action plans intended to increase clinical study enrollment of participa...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...
Federal Register notice: FDA requests comments on its Information Technology Strategy and Customer Experience Strategy.
FDA clears a Tempus AI 510(k) for its Tempus ECG-AF device that uses artificial intelligence to help identify patients at increased risk of atrial fib...
