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In July 1992, the Center for Biologics Evaluation and Research (CBER), which is what biologics regulation is still called at the FDA today, issued the first license for a treatment of chronic Hepatitis B for recombinant interferon alfa-2b. FDA had previously approved this for other indications, including hairy cell leukemia. CDC estimated at that time 750,000 to 1 million Americans had the Hepatitis B virus, and one-quarter would develop chronic, active hepatitis.
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