K*C
发帖数: 2825 | 1 Clinical Trials在美国做和在中国做在FDA审批上有什么区别没有 | j******w
发帖数: 97 | 2 9. Must a sponsor conduct a foreign clinical study under an IND?
No. A sponsor may choose, but is not required, to conduct a foreign clinical
study under an IND. When a foreign clinical study is conducted under an IND
, all FDA IND requirements must be met unless waived (see #12 and #13 below)
. When the foreign clinical study is not conducted under an IND, the sponsor
must ensure that this study complies with 21 CFR 312.120, “Foreign
clinical studies not conducted under an IND,” if the sponsor intends to
submit the study to FDA to support clinical investigations conducted in the
United States and/or marketing approval. An application based solely on
foreign clinical data must meet criteria listed in 21 CFR 314.106.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UC | c**********d
发帖数: 389 | 3 Conducting Clinical Trails outside of the US general has nothing to do with
FDA. Most time you cannot use the data in IND either. The company I work
for is going through these decisions.
【在 K*C 的大作中提到】
: Clinical Trials在美国做和在中国做在FDA审批上有什么区别没有
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