eCTD Validation Criteria v2.2 FAQs

GlobalSubmit recently held an educational webinar on the Understanding the New FDA Validation Criteria. The purpose of the webinar was to provide an overview of the US FDA’s draft version of the new “Specification for eCTD Validation Criteria,” which outlines many of the new error conditions that the FDA will be checking for in the next version of its validation software. During the webinar, facilitated by Daniel Clark, Sr. Manager,...

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Next RPS Ballot Delayed Until September 2011

The May 2011 ballot date was missed and is now delayed until September 2011. Why was the date missed? In my opinion, we are still working on refining all of the requirements. We have two requirements left to be finalized; namely, being able to reuse studies and all of the components in two applications and support for the new European variation legislation.

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Federal Information Processing Standards (FIPS) and MD5 Checksums

There is an old security requirement that the United States Federal government imposes that will affect the FDA. That security requirement, otherwise known as Federal Information Processing Standards (FIPS), does not allow any program to calculate MD5 checksums, as defined in the eCTD 3.2 specification. This is a potentially huge problem for everyone creating eCTD submissions. What is the FIPS? The Federal Information Processing...

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RPS Ballot Passes, Working Group Now Evaluating Comments

Our posting this time is from Jason Rock, GlobalSubmit CTO and Chair of the HL7 RPS Specification Development Group. The Draft Standard for Trial Use (DSTU) ballot of the Regulated Product Submission Release 2 standard barely passed ballot on Monday January 11th. The ballot passed by two votes with a result of 53 affirmative and 33 negative. Even though the ballot passed, the process is not over. Every comment must be evaluated. This...

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RPS Working Group Reviews ICH Requirements

The RPS (Regulated Product Submissions) Working Group met last week in Atlanta. The main discussion points were around ICH requirements, multi product submission, facility submissions, linking to other applications, multi regulator submission and how should the project be managed going forward. All current ICH requirements were reviewed. Most of the requirements are already met. Some more requirements need to be addressed. I expect...

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