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

Streszczenie

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #106 entitled "The Use of Published Literature in Support of New Animal Drug Approvals." This guidance replaces existing guidance #106, "The Use of Published Literature in Support of New Animal Drug Approvals," which FDA published in August 2000. It addressed the use of a single scientific 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.