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Health Law and Policy Commons

Open Access. Powered by Scholars. Published by Universities.®

2012

Science and Technology Law

Regulation

Articles 1 - 2 of 2

Full-Text Articles in Health Law and Policy

Beyond Abortion: Human Genetics And The New Eugenics, John R. Harding Jr. Nov 2012

Beyond Abortion: Human Genetics And The New Eugenics, John R. Harding Jr.

Pepperdine Law Review

No abstract provided.


Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer Dec 2011

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 ...