In 2011, I wrote a guest post over at The eCTD Summit about transitioning from paper to eCTD submissions. Surprisingly, much of the advice in that post 6 years ago is still applicable, but the process is even easier today. FDA’s deadline for converting marketing applications...

Confused

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. We included the appropriate metadata along with the necessary documents in Module 3.2.P. However, drug products B and C are proprietary...