Law Commons^™

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

Finding A Cure: The Case For Regulation And Oversight Of Electronic Health Record Systems, Sharona Hoffman, Andy Podgurski

Faculty Publications

In the foreseeable future, it is likely that the familiar, paper-based patient medical files will become a thing of the past. On April 26, 24, President George W. Bush announced a plan to ensure that all Americans' health records are computerized within ten years and to establish a National Health Information Network. Many advocates are enthusiastically promoting the adoption of health information technology (HIT) and electronic health record (HER) systems as a means to improve U.S. health care.

HER systems often not only serve as record-keeping systems, but also have multiple capabilities, including drug ordering, decision support, alerts concerning patient …

The Regulation Of Nanomedicine: Will The Existing Regulatory Scheme Of The Fda Suffice?, Shanna Harris

Richmond Journal of Law & Technology

Nanotechnology is the science and technology of manipulating molecules and atoms at the molecular level to create devices with new molecular properties, organizations and functions.1 Devices such as new computers that are billions of times more powerful than any currently available2 and boxes the size of sugar cubes that can hold the entire content of the Library of Congress are examples of the power of nanotechnology.

Will The Federal Circuit’S Eli Lilly V. Teva Decision Lead To Efforts To Abuse The Modification Provision Of The Hatch-Waxman Act?, Claire K. Comfort

Richmond Journal of Law & Technology

The Hatch-Waxman Act provides a mandatory thirty-month stay on the Food and Drug Administration’s (FDA) approval of an Abbreviated New Drug Application (ANDA) when a patent infringement suit is filed. The Act includes a provision for a district court to shorten or extend the Act’s thirty-month stay on FDA approval if “either party to the action failed to reasonably cooperate in expediting the action”