The CDER Office of Pharmaceutical Quality outlines its accomplishments in 2023 under four strategic priorities.
Several stakeholder organizations say they appreciate that FDA revised its draft guidance on regulatory review assessments and suggest some additional...
FDA warns Mexicos Betone SA de CV about CGMP violations in its manufacturing of finished drugs.
FDA warns San Diego, CA-based Agena Bioscience about multiple violations in its manufacturing of a colon diagnostic panel as part of its MassARRAY4 sy...
FDA warns Beckman Coulter about QS regulation violations at its Chaska, MN, manufacturing facility.
FDA posts 20 potential signals of serious risks/new safety information from the fourth quarter of 2023.
Rep. David Schweikert introduces legislation to require HHS to approve a fast-track designation for treatments for addictive substances and give the t...
FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.
