FDA retires Medwatch to manufacturer program

The FDA has retired its MedWatch to Manufacturer Program as of July 31, 2020, in favor of the FDA Adverse Event Reporting System (FAERS).

Created in 1993, the program had allowed participating drug and biologic manufacturers to receive information from the FDA on serious adverse event reports submitted directly to the agency for new molecular entities and original biologics for the first three years after approval.

The agency said FAERS provides manufacturers the same information within the same time frame or more quickly.

The FAERS Public Dashboard is an interactive application, which enables the user to search and download publicly available information from adverse event reports in FAERS, including adverse event reports submitted voluntarily to FDA for information reported to the FDA by the pharmaceutical industry, healthcare providers and consumers. Information in the dashboard is updated quarterly.

The dashboard is a highly interactive web-based tool that allows public users to search and download publicly available information from adverse event reports in FAERS, including adverse event reports submitted voluntarily to FDA.

The dashboard offers manufacturers ways of searching for and organizing data on adverse events reported to the FDA for many human drug and biologic products.

The dashboard does not provide case narratives; these can be obtained by submitting a (Freedom of Information Act (FOIA) request.

Reference:

https://www.fda.gov/safety/reporting-serious-problems-fda/medwatch-manufacturer-program