💊FDA Determines Regulatory Review Period for LITFULO Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LITFULO 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 drug product.
Learn More💊FDA Announces Regulatory Review Period for SKYCLARYS Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SKYCLARYS 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 drug product.
Learn More💊FDA Determines Regulatory Review Period for ELREXFIO Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELREXFIO 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🏥CMS Agency Information Collection Activities Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More💰NIH Closure Notices for Grant Application Review Meetings
The Department of Health and Human Services announced closed meetings of the National Institutes of Health's Center for Scientific Review to evaluate grant applications. These meetings, which will occur virtually, will not be open to the public due to the confidential nature of the discussions, including sensitive patentable materials and personal data.
Learn More⚙️FDA Classifies Coagulation System for Blood Measurement Devices
The Food and Drug Administration (FDA, Agency, or we) is classifying the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients 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 coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients' 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🧪FDA Classifies Cytomegalovirus Detection Device for Regulatory Ease
The Food and Drug Administration (FDA, Agency, or we) is classifying the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection 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 cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection'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💊FDA Notice on Drug Products Not Withdrawn for Safety Reasons
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Learn More💡NIH Licensing Opportunities for Novel Tissue Oximeter Technology
The National Institute of Child Health and Human Development (NICHD), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the licensing or collaboration opportunities for the inventions listed below, which are owned by an agency of the U.S. Government and are available for licensing and collaboration to achieve expeditious commercialization of results of federally-funded research and development.
Learn More🩺FDA Classifies Non-Microbial Analytes Detection Device
The Food and Drug Administration (FDA, the Agency, or we) is classifying the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections 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 measure non-microbial analytes to aid in the detection and identification of localized human infections' 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.
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