💊FDA Regulatory Review Period Determination for LAMZEDE Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAMZEDE 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 Classifies Medical Device for Microbial Nucleic Acids Detection
The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens 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 device to detect and identify microbial nucleic acids by FISH in clinical specimens 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🧬Executive Order 14292
Executive Order 14292 focuses on improving the safety and security of biological research in the U.S. It addresses the risks associated with dangerous gain-of-function research, emphasizing the need for stricter oversight, accountability, and compliance measures to protect public health and national security while maintaining the U.S. leadership in biotechnology and health research.
Learn More🧬FDA Draft Guidance on Disease Risks in Human Cells, Tissues
The Food and Drug Administration (FDA or the Agency) is withdrawing two final guidances entitled "Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and "Recommendations to Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and reissuing them as draft guidances.
Learn More💡NIH Announces Closed Meetings for Grant Application Review
The Department of Health and Human Services announces several upcoming closed meetings by the National Institutes of Health's Center for Scientific Review. These meetings will evaluate grant applications on various topics, ensuring that scientific advancements in health and medicine are reviewed with confidentiality for trade secrets and personal information.
Learn More💉Exclusive Patent License Opportunity for Cancer Treatment Drug Delivery
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the patents applications listed in the Supplementary Information section of this notice to Sangam Lifesciences, Inc. (Sangam), a company located in Denver, Colorado.
Learn More💰NIH Announces Closed Meetings for Grant Evaluations in June 2025
The Department of Health and Human Services has announced closed meetings for the National Institutes of Health's Center for Scientific Review. These meetings, scheduled for June 2025, will focus on reviewing and evaluating grant applications related to various scientific fields, including cancer therapeutics and neurobiology.
Learn More🧠NIH Notice
The Department of Health and Human Services announces closed meetings of the National Institute of Neurological Disorders and Stroke to review grant and cooperative agreement applications. These meetings, held virtually, are pivotal for assessing funding proposals related to neurological research, emphasizing the confidentiality of discussions and commercial interests involved.
Learn More💡Upcoming NIH Closed Meetings on Grant Applications
The Department of Health and Human Services announces closed meetings by the National Institutes of Health's Center for Scientific Review, focusing on the evaluation of grant applications related to various scientific fields. The meetings will discuss confidential materials, emphasizing the importance of protecting sensitive information while assessing funding opportunities.
Learn More🧬National Human Genome Research Institute Grant Meeting Notice
The National Human Genome Research Institute announces a closed meeting of the National Advisory Council for Human Genome Research to review and evaluate grant applications. The session, taking place virtually, will address sensitive topics including confidential trade secrets and personal information related to the applications under consideration.
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