Hepatitis was a major focus of the Bureau of Biologics’ blood regulatory program early on, from checking the proficiency of blood banks to conduct hepatitis tests, to collaborative research on the virus using animal models with National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC), to further study of donor selection criteria.
Following two meetings of its external advisory Panel on Safety and Effectiveness, which considered published and unpublished data on coordinated clinical trials conducted across the nation, the advisors broadly concurred with the Bureau that Hepatitis B immune globulin was safe and effective for Hepatitis B prophylaxis. Thus, in 1977 the Bureau issued the first license for this product in post-exposure prophylaxis in the event of accidental encounters such as needle sticks, laboratory accidents, and similar situations.
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Linda Smallwood of the FDA Bureau of Biologics checks a kit used by blood banks and other facilities to test blood for hepatitis (from FDA Consumer November 1977).
