Are you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you  take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.

Beginning December 17, 2016, be it new drug applications (NDAs), biological license applications (BLAs) or abbreviated new drug applications (ANDAs), the study data that organizations use for compliance must be aligned with the US FDA listed data standards. However, in the case of commercial INDs, FDA says that the requirement starts only after December 17, 2017.

Making it more stringent in terms of enforcing deadlines, the FDA says that technical rejection criterion is being added to the existing electronic Common Technical Document (eCTD) validation criteria. The FDA, on its website, is expected to give 30 days’ notice to the industry prior to the technical rejection criteria becoming effective.

For the electronic submissions that do not have compliant study data with respect to the data standards catalogue,  the FDA may refuse to file (RTF) for NDAs and BLAs, or refuse to receive (RTR) for ANDAs.

Types of submissions to which the standards apply to:

As per the guidance, while submitting applications to Centre for Drug Evaluation and Research (CDER) and the Centre for Biologics Evaluation and Research (CBER), organizations must consider complying with FDA’s data standards for following types of applications:

  • NDAs, ANDAs, BLAs, and all subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect.
  • Commercial INDs (for products that are intended to be distributed commercially).


  • a Trial Summary Dataset (ts.xpt) must be provided for each study even if the study started prior to Dec 17, 2016
  • a Nonclinical legacy data in PDF format should be submitted along with a TS dataset

The study data validation WILL APPLY to following eCTD sections:

  • Study Reports
  • Clinical Study Reports and Related Information

The study data validation WILL NOT APPLY to:

  • Pharmacology
  • Pharmacokinetics
  • Genotoxicity
  • Reproductive and Developmental Toxicity
  • Local Tolerance
  • Other Toxicity Studies
  • Literature References
  • Reports of Bioanalytical and Analytical Methods for Human Studies
  • Reports of Analyses of Data from More than One Study
  • Other Study Reports and Related Information
  • Reports of Post-marketing Experience

Apart from keeping abreast with study data market updates and mandates, organizations might face challenges to get a real-time visibility into multi-site clinical studies for end-to-end compliance. Enabling them efficiently manage the operational complexities, Freyr offers a suite of Regulatory software solutions for submissions and publishing and trial master files. Know more.


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