Department of Health and Human Services March 26, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; EMTRIVA
The Food and Drug Administration (FDA) has determined the regulatory review period for EMTRIVA 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; NOVOLOG
The Food and Drug Administration (FDA) has determined the regulatory review period for NOVOLOG 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ONYX LES
The Food and Drug Administration (FDA) has determined the regulatory review period for ONYX LES 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 medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; PREVICOX
The Food and Drug Administration (FDA) has determined the regulatory review period for PREVICOX 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 animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; REVLIMID
The Food and Drug Administration (FDA) has determined the regulatory review period for REVLIMID 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.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Determination That DURICEF (Cefadroxil USP) Tablets, 1 Gram, and Capsules, 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DURICEF (cefadroxil USP) Tablets, 1 gram (g), and Capsules, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve abbreviated new drug applications (ANDAs) for cefadroxil USP tablets, 1 g, and cefadroxil USP capsules, 500 mg.
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