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FDA Week - 08/09/2019

Lawyer: FDA Could Exclude More Bulk Substances After Athenex Ruling

By David Roza
August 2, 2019 at 7:15 PM
An industry lawyer expects FDA will exclude several more substances from its 503B bulks list now that a federal court has sided with the agency in a lawsuit challenging its process for evaluating which substances can compounded by outsourcers. The DC federal district court on Thursday (Aug. 1) backed FDA’s decision to exclude vasopressin from the list on the grounds that patients’ clinical needs could instead be met by an FDA-approved product. The lawsuit cements FDA’s interpretation of the Drug...


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