FDA Updates Technical Guidance for Clinical Trial Data Compliance

The Food and Drug Administration (FDA) has published the March 2025 edition of the "Study Data Technical Conformance Guide". This guide provides specifications, recommendations and general considerations on the submission of standardized clinical study data using FDA-supported data standards as described in the FDA Data Standards Catalog.

The document complements the regulatory guidance"Providing Regulatory Submissions in Electronic Format - Standardized Study Data" (eStudy Data), which implements the electronic submission requirements set forth in section 745A(a) of the Federal Food, Drug, & Cosmetic Act (FD&C Act). This regulation applies to standardized data submitted in certain regulatory proceedings, including Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs), when directed to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

With this update, the FDA is reinforcing the need to comply with established data standards in order to increase the consistency, efficiency and quality of regulatory submissions. Proper use of the guidelines presented in the guide is essential to ensure that the data submitted is accepted without delays or complications due to formatting problems or inadequate structuring.

The "Study Data Technical Conformance Guide" can be consulted in full below, and it is recommended that manufacturers of these products take a close look at its guidelines to ensure compliance with regulatory requirements.