Allergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Allergic Rhinitis: Developing Drug Products for Treatment." The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on February 16, 2016.