💊FDA Revokes Emergency Use Authorizations for COVID-19 Drugs
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Regeneron Pharmaceuticals, Inc. (Regeneron) for REGEN-COV (casirivimab and imdevimab administered together), to GlaxoSmithKline LLC (GSK) for sotrovimab, to Eli Lilly and Company (Lilly) for bebtelovimab, and to AstraZeneca Pharmaceuticals LP (AstraZeneca) for EVUSHELD (tixagevimab co-packaged with cilgavimab). FDA revoked these Authorizations on December 13, 2024, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in this document.
Learn More📋FDA Medical Device Reporting Requirements and Compliance 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.
Learn More🐾FDA Notice on Compounding Animal Drugs from Bulk Substances
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.
Learn More📄New Privacy Act Regulation for Navy's Midshipmen Records
In accordance with the Privacy Act of 1974, the Department of Navy is publishing a new system of records titled, "Midshipmen Development Center (MDC) Records," N01531-2. This system is being established to support the psychological and nutritional well-being of midshipmen at the United States Naval Academy. The system will enable the Midshipmen Development Center to collect and maintain records that cater to the unique needs of the Brigade of Midshipmen, promoting their overall development and success. Records include documentation of individual and group counseling sessions, psychological evaluations, treatment for eating disorders, crisis intervention services, consultations with psychologists, and performance enhancement support provided to midshipmen.
Learn More🏥TRICARE Regulation Expands Coverage for Clinical Trials
The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this final rule regarding circumstances under which services and supplies related to emerging treatments may be covered under the TRICARE program. This rule finalizes provisions published in two interim final rules (IFRs) with request for comment, which temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. This final rule discusses the DoD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. Lastly, the final rule expands TRICARE's clinical trial benefit by covering services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials that are NIH-sponsored or approved and that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life- threatening, or a rare disease.
Learn More📋CMS Agency Information Collection Activities & Compliance Requirements
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🚫DEA Revokes Registration of Dr. Taha Dias for Prescription Violations
The Drug Enforcement Administration issued a decision to revoke the DEA Certificate of Registration for Dr. Taha Dias, citing repeated violations of federal and Florida state law related to the improper issuance of prescriptions for controlled substances without legitimate medical purpose, jeopardizing public safety and regulatory compliance.
Learn More📄VA PCAFC Decision Appeal Form Information Collection Notice
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration (VHA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden, and it includes the actual data collection instrument.
Learn More💼Annual Pay Ranges for VHA Physicians, Dentists, and Podiatrists
VA is hereby giving notice of annual pay ranges, which is the sum of the base pay rate and market pay for VHA physicians, dentists, and podiatrists as prescribed by the Secretary for Department-wide applicability. These annual pay ranges are intended to enhance the flexibility of the Department to recruit, develop, and retain the most highly qualified providers to serve the Nation's veterans and maintain a standard of excellence in the VA health care system.
Learn More🏥Notice of Special Medical Advisory Group Meeting by VA
The Department of Veterans Affairs announces an open meeting of the Special Medical Advisory Group, aimed at advising on veterans' healthcare issues. The meeting provides a platform for public comments and discussions on critical topics, including suicide prevention and community care strategies, emphasizing veterans' needs and healthcare treatment improvement.
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