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FDA Principal Deputy Commissioner Amy Abernethy announced on Tuesday that the agency will clarify its regulatory approach to cannabidiol products in light of the increasing illegal marketing of CBD products as FDA approved.
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The FDA’s Office of Prescription Drug Promotion sent an untitled letter to Rockwell Medical of Wixom, Michigan over its web page for Triferic (ferric pyrophosphate citrate), an iron-replacement for adults with hemodialysis-dependent chronic kidney disease.
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Novartis has forged a merger agreement with The Medicines Company under which it will buy up the firm’s cholesterol drug inclisiran for a whopping $9.7 billion. Read More
The FDA hit Florida stem-cell supplier RichSource Stem Cells with an untitled letter for unapproved claims relating to its RICHGEN stem cell product.
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In a move to help sponsors of insulin biosimilar applications, the FDA spelled out the data and information needed to support immunogenicity assessments for insulin biosimilars or interchangeables in a draft guidance released on Monday.
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