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...
The National Academies produces a book on improving representation for women and minorities in clinical trials and research.