Department of Health and Human Services March 20, 2006 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; MYCAMINE
The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Memorandum of Understanding Between the United States Food and Drug Administration, the National Cancer Institute, and the Centers for Medicare and Medicaid Services
The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Centers for Medicare and Medicaid Services (CMS) to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goal of improving the clinical utility of biomarker technologies as diagnostic and assessment tools that facilitate the development of safer and more effective cancer therapies. This collaboration among FDA, NCI, and CMS shall be known as the Oncology Biomarker Qualification Initiative.
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