FDA Issues Draft Guidances to Help Facilitate the Development of New Animal Drug Submissions

Today the U.S. Food and Drug Administration (FDA) is announcing the availability of four draft guidance documents that, if finalized, will help encourage animal drug sponsors to use innovative approaches as they prepare data submissions related to new animal drug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 the 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.

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