FDA publishes a table with information on 14 drug submissions in FY 2023 that contained real-world evidence.
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FDA publishes a draft guidance on the content and format of certain diversity action plans intended to increase clinical study enrollment of participa...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...
FDA warns Cartersville, GA-based Sani-Care Salon Products about CGMP violations in its work as a contract manufacturer of finished drugs.
FDA warns the Carmel, IN-based Indiana Lions Eye Bank about deviations from the regulations for human cells, tissues, and cellular and tissue-based pr...
CDER Office of New Drugs Special Program Staff associate director Yoni Tyberg discusses the New Drug Regulatory Program modernization and its successe...
