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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Draft eCTD Validation Specification Includes 50 New Errors

The FDA has published a draft of updated eCTD validation criteria which will become final once the FDA implements a new version of GlobalSubmit VALIDATE. The new specification includes over 50 new errors which were not previously checked. Several of these errors will receive a technical rejection.

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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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Specifications for Organizing Study Datasets

A few months ago, FDA issued version 1.5.1 of Study Data Specifications. Although the changes in the new version were not great, they were significant for eCTD as a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD is delivered and has no effect on the Table of Contents that is visible to a reviewer (created from the eCTD XML backbone)....

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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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