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. [...]
eCTD Tips
Tips, advice, and news about regulatory submissions in eCTD format.
