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FDA has published a technical specifications document entitled "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug," intended to help support the regulatory evaluation of immunogenicity data

Recalls & Warnings October 13, 2016 Nutrisystem Bars Recalled Due to Listeria Risk On October 11, 2016, Nutrisystem Everyday, LLC issued a recall of one lot of its Nutricrush Chocolate Chip Cookie Dough bar because it has the potential to be contaminated with Listeria monocytogenes