The FDA evaluates over two million adverse event reports annually that are submitted to FAERS through the MedWatch Program, and to the Vaccine Adverse Event Reporting System VAERS by patients or their families or healthcare providers, as well as adverse event reports submitted by pharmaceutical companies, and this information is used by the FDA s Office of Surveillance and Epidemiology, and the Center for Biologics Evaluation and Research s Office of Biostatistics and Epidemiology, to identify safety concerns and recommend actions to improve safety
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