Adverse Event Reporting
Catch every report of a reaction wherever it arrives, file the serious ones with the FDA on time, and keep the records for six years.
Federal law requires the company named on a supplement's label to report every serious adverse event it learns about to the FDA within 15 business days, with a copy of the label. It then has to send any new medical information for a year afterward, and keep records of every adverse event report it receives, serious or not, for six years. If the label reads "Distributed by" your company, that company is you, whoever made the product.
This module sets up an intake process that catches a report whichever channel it arrives through, decides quickly whether it's serious, collects what the filing needs, and gets it to the FDA before the deadline.
What this module covers
- 1Make Sure Someone Answers the Label Contact
- 2Route Every Channel Into One Log
- 3Decide Whether It's Serious
- 4Collect the Minimum Information
- 5File Within 15 Business Days
- 6Send Follow-Ups for a Year
- 7Tell Your Manufacturer and Your Insurer
The full module is in The Foundry
The Foundry opens early January. Join the waitlist to hear first, and read the free lessons in the meantime.