Regulatory Focus™ > News Articles > CBER Announces Electronic Submission Pilot Program

CBER Announces Electronic Submission Pilot Program

Posted 28 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) announced 28 February that it intends to conduct a pilot evaluation program for a new electronic data standard format to support application reviews.

The new standard, developed by the Clinical Data Interchange Standards Consortium (CDISC), is known as the Standard for Exchange of Nonclinical Data (SEND).

"FDA believes the use of standardized SEND datasets, together with new and better analysis tools, will enhance CBER's review and evaluation of nonclinical data," said FDA in the Federal Register posting.

The pilot study should allow both industry and CBER to determine if the SEND standard assists or hinders the nonclinical study data submission process in investigational new drugs.

FDA notes that a "lack of uniformity in the formats used by sponsors to submit data [and] the inconsistent use of terminology across submissions complicates CBER's efforts to validate, display, and evaluate the data using modern computer-based review and analysis tools."


Read more:

FDA - Electronic Submission of Nonclinical Study Data; Notice of Pilot Project


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