400-9696-311 转1
400-9696-311 转2
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400-9696-311 转4
2018-09-06
FDA-2016-D-0236
指导原则
美国
现行有效
/
美国食品药品监督管理局(FDA)
GUIDANCE DOCUMENT
The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. The guidance discusses issues regarding the definition of a clinical phenotype, trial design, efficacy, and safety for new drug products under development. In particular, the guidance addresses development programs for the treatment of vasomotor rhinitis (VMR), which is a subtype of NAR.
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-2016-D-0236.
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