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July 27, 2020

FDA issues draft guidances to facilitate new animal drug submissions

The U.S. Food & Drug Administration announced July 14 the availability of four draft guidance documents that, if finalized, may encourage animal drug sponsors to use “innovative approaches as they prepare data submissions related to new animal drug products for agency evaluation and review” as part of FDA’s new animal drug approval process. The recommendations in these guidance documents align with those already issued by FDA’s other medical product centers.  Read more