by Katrina Rogers | Dec 19, 2019 | Uncategorized
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...
by Katrina Rogers | Dec 17, 2019 | Uncategorized
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...
by Katrina Rogers | Dec 12, 2019 | Uncategorized
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...
by Katrina Rogers | Dec 10, 2019 | Uncategorized
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...
by Katrina Rogers | Dec 5, 2019 | Uncategorized
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...
Recent Comments