15 Takeaways – FDA’s New Module 1
May22

15 Takeaways – FDA’s New Module 1

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.

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Automated eCTD Submission Technical Review Increases Risk of Rejection
Jun04

Automated eCTD Submission Technical Review Increases Risk of Rejection

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.

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How the FDA Reviews and Validates Regulatory Submissions
May21

How the FDA Reviews and Validates Regulatory Submissions

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.

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Risks Associated with eCTD Refusal to File (RTF)

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)...

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FDA Talks Automated Technical Rejection

At the DIA Doc Management conference, the FDA presenters spoke with one voice on their intention to start rejection sequences that have what they consider significant technical flaws. Gary Gensinger reviewed the guidance that has been issued by FDA on this topic (see my previous post) and the three types of eCTD Validation: Automated Submission Receipt (ASR) Validation – automated step performed as your submission is accepted and...

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