• Merck announces FDA acceptance of supplemental Biologics License Application for KEYTRUDA

    26 days ago - By News Medical

    Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted for standard review a new supplemental Biologics License Application for KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act, or target action, date of February 16, 2019.
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  • Seafood facility, acidified food processor warned by FDA

    Seafood facility, acidified food processor warned by FDA

    26 days ago - By Food Safety

    A seafood facility and an acidified food processor are on notice from the Food and Drug Administration for violations of the federal Food, Drug and Cosmetic Act.
    The FDA warned both companies in June this year. The warning letters were just recently posted for public view. The FDA allows companies 15 working days to respond to warning letters. If companies fail to properly correct violations, legal action can result in seizure of products and injunctions stopping operations.
    Kaltec Food Packaging Inc.
    In a June 8 warning letter to company owner Harriet L. Mascara, the FDA described...
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