FDA schedules its Science Board to the Food and Drug Administration Advisory Committee to consider challenges in evaluating the safety of dietary supp...
The Justice Department sues The Prometheus Group and its owner for allegedly recommending that single-use medical devices be used on multiple patients...
FDA warns Newbury Park, CA-based Colorful Products about CGMP violations in its manufacturing of over-the-counter topical drug products and hand sanit...
FDA warns Phoenix, AZ-based Specialty Process Labs about deviations from CGMP requirements for active pharmaceutical ingredients.
FDA authorizes a single booster shot of the Pfizer/BioNTech Covid-19 vaccine in children aged 5-11.
FDA accepts for review an scPharmaceuticals NDA for Furoscix (furosemide) delivered through an on-body infusor for treating congestion in patients wit...
Federal Register notice: FDA makes available a final guidance entitled Safety Considerations for Container Labels and Carton Labeling Design to Minimi...
Dark Horse Consulting Group submits a draft gene therapy guidance to FDA developed by former CBER staffer Donald Fink in consultation with other exper...