FDA 发布生物类似药产品标签指南最终版（FDA-2016-D-0643）
Labeling for Biosimilar Products
FDA 发布《生物类似药产品标签》最终指南，帮助申请人在 PHS 法案 351(k) 项下为拟议生物类似药制定随申请提交的标签草案。指南中的处方药标签建议主要针对处方信息，通常即说明书，仅第五部分部分建议涉及 FDA 批准的患者标签。文件编号为 FDA-2016-D-0643，公众可随时就该指南提交评论。
指南面向生物类似药 351(k) 申请，明确标签建议主要适用于处方信息，并保留随时提交评论的渠道。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2016-D-0643
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This guidance is intended to help applicants develop draft labeling for proposed biosimilar products for submission in an application under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except in for certain recommendations in section V pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use).
Submit Comments
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-0643.
来源：FDA Pharmaceutical Quality Documents · fda.gov