The United States (US) Food and Drug Administration (FDA) is taking steps towards making electronic submission of safety reports for investigational new drug applications (INDs) into their Adverse Event Reporting System (FAERS), a requirement.
The FDA have drafted a guidance detailing the electronic format that sponsors will need to use when making these submissions, for serious and unexpected suspected adverse reactions (SUSARs).
Currently, sponsors of IND applications submit safety reports via a standardised form in either paper format or as a PDF, however review and tracking of these reports has been found to be inefficient.
“The submission of this important safety information as electronic data in structured data elements will improve the FDA’s ability to review and track the safety signals that occur during the conduct of clinical trials. The FDA highly encourages sponsors of all INDs, both commercial and non-commercial, to begin submitting IND safety reports to FAERS voluntarily as soon as the new submission process is available.”
IND safety reporting via FAERS will be voluntary until two years after this guidance is finalised. Thereafter, electronic submission will be mandatory. The new submission requirements will not affect the content of submissions, timelines for reporting and other elements which need to be considered for IND safety reporting.
Creating standardised, digital IND safety reports is an important step towards more sophisticated data and technology solutions to support efficient development of safe and effective medical products. The FDA is taking these steps as part of a broader regulatory responsibility, to support innovation in medical product development.
To view the draft guidance, click here.