Rejected

For NDAs, BLAs, and ANDAs submitted to FDA, any studies started after 17 December 2016 must be accompanied by study data in standardized formats (for commercial INDs, the cutoff date for new studies is 17 December 2018). This includes both clinical and nonclinical studies. To enforce...

Scanned Documents

Scanned documents are a pain point for eCTD publishers and FDA reviewers alike. No one likes them, but, unfortunately, we all have to deal with them. In their “Portable Document Format (PDF) Specifications,” FDA attempts to minimize the inconvenience of scanned documents...

It’s likely that you’re already preparing a Development Safety Update Report (DSUR) for submission to regulatory authorities outside the US.  If so, you will be relieved to know that FDA adopted the ICH E2F Guideline.  This means that FDA will accept the DSUR to...

Health Canada

I’ve written a post today on the Ask Cato blog. It discusses the recent changes announced by Health Canada concerning their acceptance of eCTD submissions. Effective immediately, Health Canada now accepts two new submission types in the eCTD electronic-only filing format: Notifiable...