FDA Releases New Study Format Validation Rules


FDA accepts—and plans to require—submissions of drug products using electronic data submission formats adhering to accepted standards of formatting.  The appropriate use of those standards will soon be of critical importance, FDA recently indicated. As detailed in a February 2014 draft guidance document, Providing Regulatory Submissions in Electronic Format—Standardized Study Data, FDA has indicated that failure to use study data formats correctly may result in the agency rejecting a product application.  That considerably raises the costs of seemingly minor formatting errors, which could prevent FDA from processing an application, including investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs).

New SEND Rules

FDA is now out with new details about one study data submission format it supports, known as SEND.

In a 19 May 2014 Federal Register notice, FDA announced that new so-called “Validation Rules” have been released for SEND-formatted studies.  “Submitters of nonclinical study data can use this information to identify how FDA validates the data,” FDA explained.  “The file uploaded to FDA’s website contains a combination of conformance rules (i.e., how well the data conform to the standard) and business rules (i.e., quality checks; how well the data may support meaningful analysis). The file may be updated periodically as new or updated validation rules are developed.”

The new SEND Validation Rules may be downloaded on FDA’s Data Standards Catalogue page.

FDA’s announcement did not mention if the agency was accepting comments on the new validation rules, or when they would come into effect.

REFERENCE:  Regulatory Focus; Alexander Gaffney, RAC; 19 MAY 2014

Leave a Comment