FDA Offers Technical Rejection Criteria for Study Data

For clinical and nonclinical studies starting after 17 December 2016, the US Food and Drug Administration (FDA) is requiring the use of data standards listed in the FDA Data Standards Catalog for all new drug applications (NDAs), biologic license applications (BLAs) and abbreviated new drug applications (ANDAs).

Technical rejection criteria is being added to the existing electronic common technical document (eCTD) validation criteria to enforce the deadlines, FDA says. The agency will give industry 30 days’ notice on the eCTD website prior to the criteria becoming effective.

FDA may refuse to file (RTF) for NDAs and BLAs, or refuse to receive (RTR) for ANDAs, an electronic submission that does not have study data in conformance to the required standards specified in the FDA Data Standards Catalog.

The standards apply to the following types of submissions to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER):
• 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).

In terms of deadlines, FDA says that in addition to the new requirement for studies starting after 17 December 2016, for commercial INDs, the requirement to use data standards listed in the FDA Data Standards Catalog starts after 17 December 2017.

“Although CDER and CBER can RTF or RTR submissions that do not conform to the required standards, we will implement a process to assess high-level study data standards conformance at the time the submission is submitted and validated,” FDA says.

The agency also noted that a Trial Summary dataset (ts.xpt) must be presented even if the study started prior to 17 December 2016.

Study data validation will apply to the following eCTD sections:
• 4.2 Study Reports
• 5.3 Clinical Study Reports and Related Information

Study data validation will not apply to the following eCTD sections:
• 4.2.1 Pharmacology
• 4.2.2 Pharmacokinetics
• 4.2.3.3 Genotoxicity
• 4.2.3.5 Reproductive and Developmental Toxicity
• 4.2.3.6 Local Tolerance
• 4.2.3.7 Other Toxicity Studies
• 4.3 Literature References
• 5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
• 5.3.5.3 Reports of Analyses of Data from More than One Study
• 5.3.5.4 Other Study Reports and Related Information
• 5.3.6 Reports of Postmarketing Experience

Technical Rejection Criteria for Study Data