The FDA has published a draft guidance establishing the mandatory use of the eSTAR electronic template for all Q-Submissions, including Pre-Submissions, within the scope of medical device regulation. This proposal aims to improve the quality, consistency and traceability of submissions made to the FDA, progressively replacing free formats with a structured, digital template.

The FDA has released the March 2025 edition of the "Study Data Technical Conformance Guide", an essential document for ensuring regulatory compliance in the submission of standardized data in clinical studies. The new guidelines affect processes such as INDs, NDAs, ANDAs and BLAs, ensuring that manufacturers follow the standards of the FDA Data Standards Catalog. Compliance with these rules is key to avoiding delays and guaranteeing acceptance of electronic submissions to CDER and CBER.