FDA Retires MedWatch to Manufacturers Program

The FDA has retired its MedWatch to Manufacturer Program 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.