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...

eCTD Best Practices

GlobalSubmit published a guest post by me today titled, “Best Practices for eCTD Publishing,” on their blog, The eCTD Summit.  The post outlines five strategies that we employ in my organization for successful eCTD submissions publishing, which are: Partner with your...

Transition to an eCTD NDA

At a recent meeting of the NCRAF eCTD Group, I learned that several of my colleagues there have fielded questions from clients who believed that an eCTD NDA is just an extension of the IND.  In other words, it’s just a new sequence number filed under the IND.  One person even...