Q: FDA forms have PDF security. Is this a problem in validation, and if so, how should it be dealt with?
A: Any file in the forms sections will not be validated again PDF checks; for example, PDF security. Forms have special validation; for example, ensuring that the application number is correct.
Q: Some ICH regions have provided free validation tools as a collaborative effort between agency and vendor. Does FDA/GlobalSubmit have any plans to provide a free validation tool to industry?
A: Currently neither GlobalSubmit nor the FDA has plans to provide free validation tools to the industry.
Q: When will the new FDA Validation criteria version 2.0 be implemented at the agency? The FDA website says November 2011. Is this still the timeframe?
A: No, the tentative date is February 2012.
Q: How do we get a list of validation errors from the FDA from each of our submissions?
A:You should request the validation errors from your Project Manager.
To find more Q&A information please click here: THE eCTD SUMMIT: Webinar Recap: Understanding the New FDA Validation Criteria – Q&A
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