💊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.
Learn More💊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.
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