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GUIDANCE DOCUMENT

Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry September 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2000-D-0277
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2000-D-0277.

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