🩺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.
Learn More💊FDA Notice on Drug Products Not Withdrawn for Safety Reasons
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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💉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🏥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⚖️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🏥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📅NIH Grant Review Committee Meetings
The Department of Health and Human Services announces closed meetings of various National Institutes of Health committees to review grant applications. The meetings aim to evaluate proposals within specific sectors, emphasizing the confidentiality of trade secrets and personal data. These sessions provide valuable insights into funding opportunities for businesses involved in health-related research and development.
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💊FDA's Generic Drug User Fee Program Information Collection Overview
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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