Not using electronic signatures to sign Forms FDA 356h or 1571? That’s okay, but you will need to know how to avoid validation errors on scanned FDA forms.
The US FDA is rolling out a new and improved Module 1 in less than three weeks. Are you ready? Here is a regulatory intelligence primer based largely on the information that was divulged at the recent DIA eRI conference in Philadelphia.
Currently, a submission is loaded onto the Agency server and run through validation software. Error reports are then generated, and subsequently reviewed for legitimacy by a member of the FDA team. Once the fully-automated system is implemented, detection of a high-level error could meet the system’s threshold, and trigger technical rejection. A high-level error might simply be a case of misinterpreting FDA guidance, or using a publishing tool not updated with the latest validation criteria.
Besides loading and validating submissions, VALIDATE is used to reject submissions for technical reasons. If VALIDATE reports a high error, your submission could be rejected. This rejection could take up to five days to be reported. When an original or supplement is rejected, your PDUFA time clock will not start.
Recently, eCTD has been in the news in a big way. Acorda Therapeutics announced that it received a refuse to file (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). The FDA has raised what it termed “format issues” regarding Acorda’s eCTD (electronic)...