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Semiprocedural Judicial Review, Ittai Bar-Siman-Tov
Semiprocedural Judicial Review, Ittai Bar-Siman-Tov
Dr. Ittai Bar-Siman-Tov
This Article explores a novel cross-national phenomenon: the emergence of a new judicial review model that merges procedural judicial review with substantive judicial review. While this model is not yet fully defined, it has already spurred much controversy. The Article explicates this emerging model, which it terms 'semiprocedural review,' and provides a theoretical exploration of both its justifications and its objectionable aspects. It concludes by evaluating semiprocedural review's overall justifiability and suggesting guiding principles for a more legitimate model of semiprocedural review. The Article pursues these goals through the unique perspective of juxtaposing semiprocedural review with 'pure procedural judicial review' …
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 …