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...
Uncategorized
Electronic Regulatory Submissions Part 16
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...
Electronic Regulatory Submissions Part 15
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...
Electronic Regulatory Submissions Part 14
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...
Electronic Regulatory Submissions Part 13
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...
Electronic Regulatory Submissions Part 12
CTD Organization Makes Finding Information Simpler (Note: This post is part of a multi-part series on the CTD this fall) Part of what makes the CTD so useful is its internal structure. We can look at the Quality Overall Summary (QOS) as an example (see the M4Q...
Electronic Regulatory Submissions Part 11
What’s in Module 5 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 5 contains the clinical study reports about the new drug. The overview and summaries for these studies are included in module 2 sections 5 and 6. Module 5...
Electronic Regulatory Submissions Part 10
What’s in Module 4 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 4 contains the nonclinical study reports about the new drug. The overview and summaries for these studies are included in module 2 sections 4and 6,...