Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
[3] Section 351 of the Public Health Service Act requires licensure of biological products that travel in interstate commerce in the United States.
[citation needed] Section 361 of the same act allows the Surgeon General to make and enforce regulations to control the interstate spread of communicable disease.
[citation needed] As of 2003, the Vaccine Adverse Event Reporting System was based on a data integration platform from Informatica.
[7] CBER's history began with a horse named Jim, a vaccine-contamination scandal that prompted the Biologics Control Act of 1902.
In 1987, under Commissioner Frank Young, CBER and the Center for Drug Evaluation and Research (CDER) were split into their present form.
[8] CBER took a more collaborative, public-health driven approach to working with the industry, and in the 1980s was quicker to approve products than their drugs counterparts.
[8] In 1997, Congress re-authorized user fees, and research previously done at taxpayer expense began to be charged to manufacturers.
[8] Federal law and DHS policy define the procedures for the CBER to establish advisory committees,[9] which may further be divided into panels and must be renewed every two years.