FDA Announces the Retirement of the MedWatch to Manufacturers Program

FDA Announces the Retirement of the MedWatch to Manufacturers Program  

The U.S. Food and Drug Administration is announcing the retirement of the MedWatch to Manufacturer Program (MMP). The program provided participating drug and biologic applicants with a way to receive information from FDA on serious adverse event reports that are submitted directly to FDA by voluntary reporters. Before the program was created in 1993, applicants had limited ways to request this information. 

Since the introduction of the FDA Adverse Event Reporting System (FAERS) Public Dashboard in 2017, applicants have been able to directly search and download the voluntary reports. The dashboard allows applicants to obtain the information on voluntary reports within the same time frame or more quickly than they received this information via the MMP. The MMP retirement will not impact access to the voluntary reports because the dashboard provides increased access and transparency using the interactive, web-based tool.

As of July 31, 2020, the MMP was retired and the FAERS Public Dashboard will continue to be available to provide manufacturers with increased direct access to adverse event report information. For more information on the retirement of the MMP, please visit the MedWatch to Manufacturer Program webpage.