On Nov. 21, 1997, the FDA Modernization Act (FDAMA) was signed into law, amending the Food, Drug and Cosmetic Act and the Public Health Service Act to modernize the regulation of food, medical products, and cosmetics. FDAMA initiatives included measures to modernize the regulation of biological products. Specifically, changes included eliminating the need for establishment license applications, streamlining the approval processes for manufacturing changes, and reducing the need for environmental assessment as part of a product application.