E5: Ethnic Factors in the Acceptability of Foreign Clinical Data Questions & Answers (R1)

Regulatory Resource: E5: Ethnic Factors in the Acceptability of Foreign Clinical Data Questions & Answers (R1)

Description:

Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the E5 guideline have resulted in the need for some clarification. This supplementary Questions and Answers document intends to clarify key issues.

Download Document: E5: Ethnic Factors in the Acceptability of Foreign Clinical Data Questions & Answers (R1)

0.06 Megabytes