Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 3 of 3
Full-Text Articles in Health Law and Policy
Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Saint Louis University Journal of Health Law & Policy
Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome …
Introducing Patient Scope Of Care: Psychologists, Psychiatrists, And The Privilege To Prescribe Drugs, Rachel P. Berland
Introducing Patient Scope Of Care: Psychologists, Psychiatrists, And The Privilege To Prescribe Drugs, Rachel P. Berland
Saint Louis University Journal of Health Law & Policy
No abstract provided.
Independent Clinical Trials To Test Drugs: The Neglected Reform, Marc A. Rodwin
Independent Clinical Trials To Test Drugs: The Neglected Reform, Marc A. Rodwin
Saint Louis University Journal of Health Law & Policy
No abstract provided.