Review of Thimerosal by the Food and Drug Administration as Required by the Food and Drugs Administration Modernization Act (1997-1999)
Over-the-counter (OTC) products and vaccines are regulated by different branches of the FDA. OTCs are regulated by the Center for Drug Evaluation and Research (CDER). Vaccines are regulated by the Center for Biologics Evaluation and Research (CBER). The FDA’s determination that mercury was unsafe and should be removed from over-the-counter medications was published in the Federal Register no fewer than five times prior to the FDA’s belated review of mercury in vaccines. What finally prompted the FDA to review mercury in vaccines was not its own regulatory process, but rather an act of Congress.
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