⚖️DEA Revocation Decision Impacting De Novo Services, LLC
The Drug Enforcement Administration (DEA) has issued an order revoking the registration of De Novo Services, LLC due to substantial violations in managing controlled substances and maintaining proper recordkeeping. The decision underscores the stringent compliance requirements enforced by federal regulations to protect public health and safety, highlighting the consequences of non-adherence.
Learn More⚖️DEA Decision on Svetlana Burtman
The Department of Justice's ruling on Svetlana Burtman highlights numerous violations of the Controlled Substances Act, including operating an unregistered practice and failing to maintain adequate records. This decision underscores the rigorous compliance requirements for healthcare providers regarding controlled substances. The ramifications may extend beyond individual practitioners, influencing broader regulatory practices in the healthcare industry.
Learn More🏥Medicare's Public Meeting on New Clinical Lab Test Codes for 2026
This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule for calendar year 2026. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
Learn More💊FDA Approves TREMFYA Under Rare Pediatric Disease Voucher
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application (Supplement-24) for TREMFYA (guselkumab), approved March 20, 2025, meets the criteria for redeeming a priority review voucher.
Learn More💊FDA Decision on MOBIC Allows Continued Generic Approvals
The Food and Drug Administration (FDA or Agency) has determined that MOBIC (meloxicam) tablets, 7.5 milligrams (mg) and 15 mg, 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More🏥Notice of Meeting for National Advisory Council on Nursing Research
The National Advisory Council for Nursing Research will hold a virtual meeting open to the public. The agenda includes discussions and reviews of grant applications relevant to nursing research, providing an opportunity for interested individuals to engage and submit comments on the council's work. Special accommodations will be available for attendees needing assistance.
Learn More⚖️DEA Revokes Registration of Dr. John Stanton Due to Legal Issues
The Drug Enforcement Administration (DEA) issued an Order to Show Cause against Dr. John Stanton, proposing to revoke his registration due to the loss of state medical authority. The decision directly relates to his felony conviction and the revocation of his medical license in Tennessee, thereby blocking his ability to dispense controlled substances.
Learn More🩺CMS Medicare Evidence Development Advisory Meeting Notice
This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) ("Committee") will be held on Wednesday, June 25, 2025.
Learn More🏥CMS Proposed Information Collection Activities and Business Impact
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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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🏥Medicare Advisory Panel Meeting on Clinical Diagnostic Tests Announcement
This notice announces the public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Wednesday, July 23, 2025, and Thursday, July 24, 2025. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.
Learn More