CDER: Guidance on NDA/BLA/ANDA Data Standards Coming in Mid-2012

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) announced on 12 January that it is planning to release new regulatory requirements by mid-2012 for electronic submissions of all study data included in New Drug Applications (NDAs), Biologics License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs).

The new regulatory requirements are a result of CDER's Data Standards Program, which is aims to create standards to facilitate rapid access, analysis, storage and reporting of regulatory data.

The new guidances would, respectively, require that all study data be submitted electronically and instruct industry on how to submit study data using existing data standards. FDA noted that the electronic submission requirements have been worked in to the Prescription Drug User Fee Act IV (PDUFA) performance goals.

CDER has also established a set of "draft working processes" that will align with its Data Standards Program that will provide guidance on how CDER will adopt, modify, implement and maintain data standards. The draft is currently being tested internally at CDER.

The Data Standards Program remains under development, and CDER has provided grants to several organizations to assist FDA in developing the standards. Fifty-seven therapeutic areas and numerous non-clinical areas have been identified for data standardization. Non-clinical needs include 'The Animal Rule', toxicology studies, reproductive studies and in vitro assays.

• 2011 Assessment of CDER's Data Standards Program
• FDA - CDER Data Standards Program