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# Changes Sought in Draft IND Safety Report Guidance
- URL: https://www.fdaweb.com/changes-sought-in-draft-ind-safety-report-guidance/
- Published: 2020-01-07T12:00:00.000Z
- Updated: 2026-09-14T15:57:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145783

TransCelerate BioPharma says it appreciates the FDA vision for streamlining the IND safety reporting process through direct submission of IND safety reports to the FDA Adverse Event Reporting System (FAERS) and looks forward to implementation. In a draft guidance [comment](https://www.regulations.gov/document?D=FDA-2019-D-3953-0006&ref=fdaweb.com), the company says that during the 24-month transition period between guidance finalization and enforcement of the submission requirement, it is not clear whether the parallel or simultaneous submission of IND safety reports via the conventional process and FAERS electronic submission will be the agency’s expectation. “We are not able to identify any potential benefits to the sponsor or the agency to submit via both pathways,” it says. “To eliminate any undue burden that dual submissions would require from sponsors, we request that the agency explicitly clarify and allow sponsors to select one path for IND safety report submission during the transition window.”

Pharmaceutical Research and Manufacturers of America (PhRMA) [says](https://www.regulations.gov/document?D=FDA-2019-D-3953-0007&ref=fdaweb.com) it agrees with FDA that the digital submission of certain IND safety reports will allow for consistent tracking of safety signals and will streamline the submission and review of safety reports. PhRMA also says that while it supports FDA implementation of a reporting format compliant with International Council for Harmonization (ICH) guidelines, there are several data elements required that are not aligned with ICH standards, for which PhRMA requests further clarification and guidance. PhRMA also notes that the scope of the draft guidance does not cover IND safety reports for events of special interest that are specifically requested by FDA in certain programs and recommends that the agency outline in the draft how they are to be reported once the guidance is in effect.