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Full-Text Articles in Law
Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer
Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer
Parker Tresemer
Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …
An Innovation-Centric Approach Of Telecommunications Infrastructure Regulation, Konstantinos Stylianou
An Innovation-Centric Approach Of Telecommunications Infrastructure Regulation, Konstantinos Stylianou
Konstantinos Stylianou
This paper considers the mechanics and role of innovation in telecommunications networks, and explains how regulation can be designed to maximize innovation. To better focus on the relationship between innovation and regulation an effort is made to distinguish innovation from competition, although the two concepts are closely related, and several reasons are presented on why the fast changing, networked and technical nature of telecommunications offers a very favorable environment for innovation to thrive, as well as why innovation benefits from a large number of actors. Moreover, the paper further explains that even small players are useful in the innovation process …