FDA CDER 年度报告 CMC 部分格式与内容指南（最终版）
Format and Content for the CMC Section of an Annual Report
美国 FDA 药品评价与研究中心（CDER）发布最终版指南，说明依据 21 CFR 314.81(b)(2) 提交的新药申请（NDA）、简化新药申请（ANDA）或简化抗生素申请（AADA）年度报告中 CMC 部分所需信息。该指南为最终版，征求意见可通过 docket ID FDA-2013-S-0610 提交。
GUIDANCE DOCUMENT
Final
- Issued by:
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Guidance Issuing Office
Center for Drug Evaluation and Research
To describe the information requested by the Center for Drug Evaluation and Research (CDER) in an Annual Report to a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Abbreviated Antibiotic Application (AADA) submitted pursuant to 21 CFR 314.81(b)(2).
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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 comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov