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