Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

FDA Modernizes Biotech Regulation Over The Past 20 Years

From a small laboratory to a highly specialized organization, the FDA has grown with the changing needs of the biotech field
Oct 1, 2007

Federal regulation of biologics began more than 100 years ago with the enactment of the Biologics Control Act of 1902. That act required licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and other similar products in order to prevent deaths from contaminated vaccines, as had recently occurred with the diphtheria antitoxin.

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