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FDA warns Newbury Park, CA-based Colorful Products about CGMP violations in its manufacturing of over-the-counter topical drug pro...[ Price : $8.95]
FDA warns Phoenix, AZ-based Specialty Process Labs about deviations from CGMP requirements for active pharmaceutical ingredients.[ Price : $8.95]
FDA authorizes a single booster shot of the Pfizer/BioNTech Covid-19 vaccine in children aged 5-11.[ Price : $8.95]
FDA accepts for review an scPharmaceuticals NDA for Furoscix (furosemide) delivered through an on-body infusor for treating conges...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Safety Considerations for Container Labels and Carton Label...[ Price : $8.95]
Dark Horse Consulting Group submits a draft gene therapy guidance to FDA developed by former CBER staffer Donald Fink in consultat...[ Price : $8.95]
The National Academies produces a book on improving representation for women and minorities in clinical trials and research.[ Price : $8.95]
FDA releases the FDA-483 with five observations from an inspection at the Columbia, MO-based Apollo Care outsourcing facility.