FDA has announced that study data standards are required for clinical and nonclinical studies that are started after December 17, 2017. FDA notes that it may Refuse-to-File (RTF) NDAs and BLAs or Refuse-to-Receive ANDAs if the data does not conform to the standards outlined in the Guidance for Industry – Providing Regulatory Submissions In Electronic Format — Standardized Study Data and to comply with the outline in this notice which can be found here.
FDA notes “[T]he standards apply to the following types of submissions to CDER and 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).”
FDA will assess each submission in accordance with the criteria outlined in the Notice at a high level in making any determination to RTF or RTR and application at the time the submission is submitted and validated.
Everyone make certain your CRO and or your eCTD team or contractor is aware of the new requirement before the deadline arrives so that they are prepared to meet the new requirements.