Recently, I’ve been working on an eCTD IND that includes three drug products, A, B, and C. Drug product A is the sponsor’s own product, and so we included the appropriate metadata for this product along with the necessary documents in Module 3.2.P. However, drug products B and C are proprietary products of other manufacturers. These two drug products are incorporated into the IND via the right of reference to their respective DMFs.
For More Information please click : eCTD Tips Metadata
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