REGULATORY UPDATE: FDA Proposes Revisions to Safety Reporting Forms

The Food and Drug Administration proposed updates to the agency’s safety reporting forms to align with current regulations, guidance documents and internal procedures. The proposed revisions, published today in the Federal Register, aim to improve the clarity and utility of MedWatch reports submitted by health care professionals, patients and industry.

Changes fall into three categories: regulatory-driven revisions, internal workflow improvements and enhancements to the way FDA processes submitted reports. While the structure of the forms remains the same, the updates include revised instructions, formatting changes and updated contact information.

FDA is accepting public comments on the proposed revisions through July 25.