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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U.S. Department of Defense Promotes Security Benefits of the Cloud

We have all heard of the high profile security breaches at the U.S. Department of Defense in the last few years — from state sponsored hackers stealing nearly 25,000 files related to new weapon systems to an army soldier providing secret documents to WikiLeaks, among others. The fact that those breaches occurred on supposedly secure systems that DOD and its industry partners have operated for years shows just how challenging...

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PDUFA V Includes eCTD Mandate for Marketing Applications, Commercial INDs

In September, the FDA issued its Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. There are many proposed improvements related to the FDA review procedures, including a mandate of the eCTD. This mandate will start 24-months after publication of the corresponding final guidance for marketing applications and 36-months after publication of the final guidance for commercial INDs and...

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FDA Accepting PDF 1.7 and Older Versions

the FDA currently accepts PDF 1.4 and will soon except PDF 1.7. Does this mean that you need to upgrade all of your PDF’s from 1.4 to 1.7? The very simple answer is no. The specifications for PDF are backward inclusive. This means that the PDF 1.7 specification includes all of the functionality previously documented in the Adobe PDF Specifications for versions 1.0 through 1.6.

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New FDA M1 Specifications include DDMAC, Bundled Submissions

As reported last month, the two significant changes to the specifications are is inclusion of DDMAC submission and bundled submissions. The largest change to FDA’s regional DTD is now one sequence can be submitted to multiple applications. This is a great feature if you create a single submission and replicate it to send to multiple applications. The only drawback to this plan is once you submit a bundled submission, the lifecycle for the document submitted cannot diverge in any of the applications.

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