⚗️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.
Learn More💰NIH Announces Closed Meetings for Grant Evaluations
The Department of Health and Human Services announces several closed meetings by the National Institutes of Health to evaluate grant applications. These meetings pertain to specific panels focused on scientific research topics, ensuring confidentiality and the protection of sensitive information while facilitating assessments that influence research funding.
Learn More🌽Draft Plant Pest Risk Assessment for Bayer Corn Available for Comment
We are advising the public that the Animal and Plant Health Inspection Service has prepared a draft plant pest risk assessment and draft environmental assessment regarding a petition from Bayer U.S.- Crop Science seeking a determination of nonregulated status for maize (corn) event MON 95379 which has been developed using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran pests. We are making the draft plant pest risk assessment, and draft environmental assessment available for public review and comment.
Learn More💊FDA Notice on Regulatory Review Period Determination for LOQTORZI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LOQTORZI 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🧪FDA Revokes Emergency Use Authorizations for COVID-19 Tests
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira COVID-19 All-In- One Test Kit and Lucira CHECK-IT COVID-19 Test Kit, MAWD Laboratories for the MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR, and Nuclein, LLC (merged with Molecular Diagnostics Inc.) for the DASH SARS-CoV-2/S Test. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Learn More💡NIH Closed Meetings for Grant Application Reviews
The Department of Health and Human Services announces closed meetings of various Integrated Review Groups to evaluate grant applications. These meetings serve as critical opportunities for funding in scientific research across multiple health-related disciplines.
Learn More💊FDA Determination on EPKINLY Patent Extension and Regulatory Review
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EPKINLY 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 patents which claims that human biological product.
Learn More💊FDA Determines Regulatory Review Period for ADBRY Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADBRY 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.
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