'1996' Starting the modern era of biologics regulation : FDA's elimination of establishment licensure and other changes

On May 14, 1996, the U.S. Food and Drug Administration (FDA) issued a new regulation eliminating the establishment licensure requirement for certain 'specified' biologics and expanded the definition of 'manufacturer' for biologic products in general. These regulatory changes are a significant change in the history of biologics regulation and are the logical culmination to the FDA's recent efforts to make modern biologics regulation conform to modern biologics technology. This regulation essentially placed modern biologics on an equal regulatory and commercial footing with traditional chemical drug products. Executives, legal counsel of biologics manufacturers, and researchers developing biologics need to review their regulatory strategies and commercial agreements in light of these extraordinary changes.