ICH common technical document comments
Executive Summary
In response to "several informal requests" from drug and biologic manufacturers, FDA extends to June 16 its comment deadline on the International Conference on Harmonization common technical document format draft guidance, published in September 2001 (1"The Pink Sheet" Sept. 10, 2001, p. 19)...
In response to "several informal requests" from drug and biologic manufacturers, FDA extends to June 16 its comment deadline on the International Conference on Harmonization common technical document format draft guidance, published in September 2001 (1 (Also see "CTD Submission Voluntary, But Recommended Instead Of NDA Format" - Pink Sheet, 10 Sep, 2001.), p. 19).... |