| http://www.w3.org/ns/prov#value | - FDA intends to consider information ??????newly acquired?????? if it consists of data, analyses, or other information not previously submitted to the agency, or submitted within a reasonable time period prior to the CBE supplement, that provides novel information about the product, such as a risk that is different in type or severity than previously known risks about the product.Id. at 2850 (empha
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