The Use of Published Literature in Support of New Animal Drug Applications; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #106 entitled "The Use of Published Literature in Support of New Animal Drug Applications." This draft guidance, when finalized, will replace the existing final guidance #106, "The Use of Published Literature in Support of New Animal Drug Approval," which FDA published in August 2000 and which specifically addressed the use of a single article to support drug approval. This revision of the guidance document considers multiple uses of the scientific literature, including narrative reviews, systematic reviews, and meta-analyses to support approval of a new animal drug.