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Regulatory Focus™ > News Articles > 2020 > 8 > MedWatch to Manufacturers program retired in favor of FAERS dashboard

MedWatch to Manufacturers program retired in favor of FAERS dashboard

Posted 03 August 2020 | By Kari Oakes 

MedWatch to Manufacturers program retired in favor of FAERS dashboard

The US Food and Drug Administration (FDA) is retiring its MedWatch to Manufacturers program, saying the FDA Adverse Event Reporting System (FAERS) public dashboard has largely supplanted the functions served by the MedWatch (MMP) program.
Since 2017, said the agency, the FAERS dashboard has given sponsors the ability to search for voluntary adverse events reports and download the reports directly. “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,” said FDA in announcing MMP’s retirement.
In a Q&A on the MMP website, FDA explained that the FAERS dashboard, which is updated quarterly and includes adverse events reports submitted by consumers, healthcare providers, and the pharmaceutical industry, “offers manufacturers ways of searching for and organizing data on adverse events reported to the FDA for many human drug and biologic products.”
FDA said that the retirement of the MMP will not adversely affect the agency’s postmarket safety monitoring program. When the program was initiated in the early 1990s, there had been no easy mechanism for manufacturers to access detailed information about postmarketing adverse events. The FAERS dashboard now fulfills the MMP’s earlier functions, said the agency. “The modernized dashboard provides public access to information related to human adverse events reported to the FDA by reporters including manufacturers and the general public.”
As before, persons wishing to know more detail about events reported in the FAERS database must submit a Freedom of Information Act request that includes the FAERS case number or numbers in order to receive a case report that includes a narrative of the adverse event.

Tags: FDA, US

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