FDA《研究用新药产品（人用与兽用）的制备》行业指南（1992年11月定稿）
Preparation of Investigational New Drug Products (Human and Animal)
美国FDA药品评价与研究中心（CDER）发布《研究用新药产品（人用与兽用）的制备》行业指南定稿，1992年11月发布。该指南针对研究用新药产品的制备提出规范。相关意见可通过案卷编号FDA-2013-S-0610以电子方式提交，或邮寄至FDA Dockets Management。
GUIDANCE DOCUMENT
Preparation of Investigational New Drug Products (Human and Animal) Guidance for Industry November 1992
Final
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Guideline of the preparation of investigational new drug products (human and animal).
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