Administrative Applications and the Phased Review Process; Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #132 entitled ``Administrative Applications and the Phased Review Process.'' This guidance defines the ``phased review process'' for reviewing application-level information during the investigational period of new animal drug development, and an ``administrative'' new animal drug application (NADA) or abbreviated new animal drug application (ANADA), the content, the procedures a sponsor should follow to submit such an application, and the intended time frame for its review.