💡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Learn More💊FDA Notice on Drug Products Not Withdrawn for Safety Reasons
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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⚙️Voriconazole Test System Classification
The Food and Drug Administration (FDA, Agency, or we) is classifying the voriconazole test 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 voriconazole test 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💉FDA Meeting on 2025-2026 COVID-19 Vaccine Formula
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will meet in an open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States. FDA is establishing a docket for public comment on this document.
Learn More⚖️DEA Registration Revocation for Prescription Violations
The Drug Enforcement Administration (DEA) issued a decision revoking a medical doctor's registration due to issuing controlled substance prescriptions without state authority, violating both federal and state law. The order underscores the importance of compliance with healthcare regulations to safeguard public health and safety.
Learn More⚖️Revocation of DEA Registration for Mohan Kaza Due to Violations
The Drug Enforcement Administration issued a decision revoking Dr. Mohan Kaza's DEA registration, citing multiple violations of the Controlled Substances Act related to improper prescribing practices. The order reveals serious concerns regarding public safety and compliance with legal standards, ultimately leading to the termination of his ability to prescribe controlled substances.
Learn More🏥Public Meeting on HCPCS Coding Revisions
This notice announces the first Healthcare Common Procedure Coding System (HCPCS) public meeting of 2025 to discuss the Centers for Medicare & Medicaid Services preliminary coding, Medicare benefit category, and Medicare payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and non- biological items and services, as well as how to register for the meeting.
Learn More🏥NIH Meeting Notice
The NIH announces a hybrid meeting of the Council of Councils, focusing on grant applications and program updates. The meeting will provide insights into funding opportunities and NIH initiatives. Participants can engage virtually or in-person, ensuring accessibility for stakeholders interested in research and funding initiatives.
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🚚FMCSA Denies ICD Exemptions for Commercial Drivers
FMCSA announces its decision to deny the applications of two individuals treated with an Implantable Cardioverter Defibrillator (ICD) who requested an exemption from the Federal Motor Carrier Safety Regulations (FMCSRs) prohibiting operation of a commercial motor vehicle (CMV) in interstate commerce by persons with a current clinical diagnosis of myocardial infarction, angina pectoris, coronary insufficiency, thrombosis, or any other cardiovascular disease of a variety known to be accompanied by syncope (transient loss of consciousness), dyspnea (shortness of breath), collapse, or congestive heart failure.
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