FDA’s Adverse Event Reporting Forms to Be Revised

Today, in the pre-publication section of the Federal Register (here), the Agency is announcing certain changes in the various Adverse Drug Event (ADE) reporting forms and establishing the information collection requirements for these forms.  The notice specifies that “[t]he proposed modifications to Form FDA 3500, 3500A and Form FDA 3500B (English and Spanish) reflect changes that will bring the forms into conformation, since the previous authorization in 2022, with current regulations, rules, and guidances.  The proposed extension to Form FDA 3500, Form FDA 3500A, and Form FDA 3500B will only have changes in the form instructions to provide clarity of reporting.  The proposed changes fall into one of three categories 1) regulatory driven revisions 2) work improvements for the Center and 3) report processing improvements.  Formatting modifications are being proposed to several fields to enhance the quality, utility and clarity of the information.  We also propose to update the mailing address add mailing address (sic) to Attn: MedWatch Program, White Oak Campus, Building 22, G0207, 10903 New Hampshire Ave., Silver Spring, MD 20993.”

The document goes on to provide the specific changes to each form, for example, revisions to the reporting of gender information to comply with “the executive order, Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, signed by President Donald J. Trump on January 20, 2025” and to “add calendar functionality to all date fields for uniformity and standardization of date format.”

For those who are required to submit ADEs as well as for those who may voluntarily report ADEs, the document spells out what changes are being made to each reporting form and provides a snapshot of the changes to expect once the new forms are made effective.  As the FDA further states in the document:

“This information collection supports FDA laws and regulations governing adverse event reports and product experience reports for FDA-regulated products.  The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b, 355, 360i, 360l, 379aa, and 393) and the Public Health Service Act (42 U.S.C. 262) authorize FDA to collect adverse event reports and product experience reports from regulated industry and to monitor the safety of drugs, biologics, medical devices, and dietary supplements.  These reporting and recordkeeping requirements are found in FDA regulations, discussed in Agency guidance, and included in Agency forms.”

Be ready for the changes!