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For FDA there is INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information | FDA. The information is rather scattered throughout the text and is pretty high level, but it's all we have from them. EU has Requirements for quality documentation concerning biological investigational ...

We generally do not submit CofAs to the IND. We put the batch analysis data in S.4.4/P.5.4. ------------------------------ Rachel Thornton Director Smyrna GA United States ------------------------------

I can only speak for CMC, and as I've said elsewhere in this thread, we don't actually submit M2.3 to the IND. However, for the products I've worked on where we had multiple INDs for the same product, we only submit the CMC info to IND#1, with a x-ref in any other INDs. However, in that case the same ...

On p.1, footnote 4, it says "Analytical procedure is interchangeable with a method or test procedure." Which says to me that it doesn't necessarily mean the SOP. That term is also used many times throughout the guidance where it obviously does not mean the SOP. ------------------------------ Rachel ...

Can you specify which M2 summaries you're referring to? ------------------------------ Rachel Thornton Director Smyrna GA United States ------------------------------