Katrina’s Blog™

On September 17th, the FDA published 53 product-specific draft guidances (PSGs) to facilitate generic drug development. 34 are brand new, and 16 (5 new and 11 revised) are for complex drug products, aligning with next week’s webinar on that topic. Nearly half are for...

The Move to eCTD v4 (Note: This post is part of a multi-part series on the CTD this fall) The eCTD version current at the time of the post is v.3.2.2, with the complete specification contained in this 2008 document. This document has the clearest explanation I’ve...

The Application Lifecycle (Note: This post is part of a multi-part series on the CTD this fall) An NDA or BLA is not a static document; rather, it is a living collection of information that evolves through the lifecycle of the drug. In the earliest lifecycle phases...

Formatting the eCTD (Note: This post is part of a multi-part series on the CTD this fall) It appears to me that the explanations on the eCTD program page are targeted towards those who build XML publishing tools rather than users. That’s one reason why the structure...

How the eCTD Works (Note: This post is part of a multi-part series on the CTD this fall) The eCTD is, at heart, an electronic structure to organize and present submission for ease of review. The specifications for the eCTD are in the FDA’s Technical Conformance...