FDA行业指南：第七类兽药主文件(用于研发和风险评估)
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#260
https://www.regulations.gov
HFA-305 5630 1061 20852
FDA-2024-D-5376
7500 20855240-402-
0611lynne.boxer@fda.hhs.gov
HFV-6 7500
20855https://www.fda.gov/animal-veterinaryhttps://
www.fda.gov/regulatory-information/search-fdaguidance-documents http://www.
regulations.gov
2025 1
Contains Nonbinding Recommendations
Draft Not for Implementation
. ........................................................................................................................................... 1
II. .......................................................................................................................................... 2
A. ................................................................................................................. 2
B. R&D .................................................................................................................... 3
C. ............................................................................................................................ 3
3 .................................................................................................................... 3
A. VII ................................................................................................. 3
B. .................................................................................................................................. 5
C. ............................................................................................................................. 5
D. VII ......................................... 5
E. .................................................................................................... 5
F. VII .................................. 10
IV. ............................................................................................................................... 11
A. ........................................................................................................... 11
B. ........................................................................................................... 11
C. ........................................................................................................................... 12
D. ....................................................................................................... 12
i
Contains Nonbinding Recommendations
Draft Not for Implementation
FDA
FDA
FDA
I.
GFI VMF
1
VMF2 VMF
VMF
VII
ACTPsIGAs
ACTPs IGA
CVM
CVM VII
CVM
GFI VMF
VII
21 CFR
511.1VMF FDA
1
3 For the purposes of this document, gene therapy products modify or manipulate the expression of a gene or alter the
biological properties of living cells by introducing a new or modified gene to treat a disease.
2 For this GFI, the term developer includes sponsors, researchers, or any other individuals interacting with CVM
through the Type VII VMF.
1 VMFs are described at https://www.fda.gov/animal-veterinary/development-approval-process/veterinary-master-
files. GFIs concerning other VMFs, i.e., Types I-VI, are not relevant to Type VII.
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作者：薛定谔的龙猫
分类：专业资料
价格：100质量币
属性：15 页
大小：3.03MB
格式：PDF
时间：2025-11-12
