Issue Date: September 6, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical, Pediatric Product Development
Status: Final
Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry
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.2 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).
Download the Guidance Document
