In the July 8, 2015, Federal Register, FDA announced it is amending its regulations to implement certain drug shortages provisions of the FDCA. The rule requires all applicants of covered approved drugs or biological products to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.
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