💊FDA Notice on ALTUVIIIO Patent Extension and Review Period
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALTUVIIIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💉Government-Owned Invention Licensing Opportunity in Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.
Learn More💉Government-Owned Invention Licensing Notice for Norovirus Antibody
The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.
Learn More💊FDA's Patent Extension Review for ROLVEDON and Its Business Impact
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROLVEDON 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More🌱Overview of Amendments to Genetically Engineered Organism Regulations
On December 2, 2024, a Federal court vacated the Animal and Plant Health Inspection Service (APHIS) final rule issued on May 18, 2020 (the May 2020 final rule) that revised APHIS' regulations governing the movement of certain genetically modified organisms and was issued under the authority of the Plant Protection Act. APHIS is therefore amending the CFR to conform the CFR to the Federal Court's vacatur of that rule. The Court's vacatur was effective December 2, 2024, and had the legal effect of vacating the May 2020 final rule in its entirety and restoring the legal effect of the pre-May 2020 regulations. These technical conforming amendments revise the CFR to reflect the court's vacatur of the May 2020 final rule.
Learn More💡Government-Owned Inventions Available for Licensing in Healthcare
The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.
Learn More💡Licensing Opportunities for Government-Owned Influenza Inventions
The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.
Learn More⚗️FDA Classifies Clinical Mass Spectrometry Devices
The Food and Drug Administration (FDA, the Agency, or we) is classifying the clinical mass spectrometry microorganism identification and differentiation system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the clinical mass spectrometry microorganism identification and differentiation system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🌱Availability of Draft EIS for Blight-Tolerant American Chestnut
We are advising the public that the Animal and Plant Health Inspection Service has prepared a revised draft environmental impact statement (EIS) and revised draft plant pest risk assessment (PPRA) evaluating the potential environmental impacts and plant pest risk that may result from the approval of a petition for nonregulated status for blight-tolerant American chestnut (Castanea dentata) from the State University of New York College of Environmental Science and Forestry. The trees have been developed using genetic engineering to express an oxalate oxidase enzyme from wheat as a defense against the fungal pathogen Cryphonectria parasitica, making American chestnut tolerant to chestnut blight. Based on a revised petition submitted by the State University of New York College of Environmental Science and Forestry, we have revised the draft EIS and draft PPRA. We are making the revised petition, revised draft EIS, and revised draft PPRA available for public review and comment.
Learn More🌸Nonregulated Status for Genetically Engineered Moth Orchid Petition
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Ishihara Sangyo Kaisha, Limited seeking a determination of nonregulated status for ISK-311NR-4 Phalaenopsis (moth orchid) which has been developed using genetic engineering to produce a blue-purple flower color. We are making the petition, draft plant pest risk assessment, and draft environmental assessment available for public review and comment.
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