FDA updates Study Data Specifications and Transmission Specifications

The U.S. Food and Drug Administration (FDA) has released an updated version 2.0 of their Study Data Specification, dated July 18, 2012.

The specification document was reorganized and received some minor editorial changes. It is available for download from the FDA website.

In addition the FDA has updated the "Specification for Transmitting Electronic Submissions using eCTD Specifications" to version 1.5, dated 2012-07-26. The only change included in the new version is the acceptance of the optional passcode encryption of a USB drive as an exception from the general password protection prohibition for submission data.

[Source: FDA]

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