FDA announces draft guidance on using literature for drug approvals.

Although the public may submit comments on any FDA guidance document at any time, the agency suggests comments on the draft guidance be submitted within 60 days to ensure that it considers the comment(s) before it begins work on the final version of the guidance document. The document provides guidance to animal drug sponsors on specific areas of the approval process where the available scientific literature may be useful to support the approval of a new animal drug application, an abbreviated new animal drug application, or a conditionally approved new animal drug application. [Extracted from the article]