CTD Submission Voluntary, But Recommended Instead Of NDA Format
Executive Summary
Common technical document submission will remain voluntary, but recommended, according to FDA's draft guidance on general considerations regarding CTD submission.
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ICH common technical document comments
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to June 16 its comment deadline on the International Conference on Harmonization common technical document format draft guidance, published in September 2001 (1"The Pink Sheet" Sept. 10, 2001, p. 19)...
ICH common technical document comments
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to June 16 its comment deadline on the International Conference on Harmonization common technical document format draft guidance, published in September 2001 (1"The Pink Sheet" Sept. 10, 2001, p. 19)...
CBER Electronic IND Final Guidance Expected In March; eCTD Coming In 2003
The Center for Biologics Evaluation & Research's final guidance on submission of electronic INDs is expected to come out in March
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