Zdrowie i gospodarka · 29/01/1996

Well-Characterized Biotechnology Products; Elimination of Establishment License Application

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate the establishment license application (ELA) requirement for well-characterized biotechnology products licensed under the Public Health Service Act (PHS Act). The proposed rule would also exempt well-characterized biotechnology products licensed under the PHS Act from certain biologics regulations and harmonize the requirements applicable to these products with those applicable to similar drug products which are approved under the Federal Food, Drug, and Cosmetic Act (the act). This action is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives, and it is intended to reduce unnecessary burdens for industry without diminishing public health protection.