💊FDA Determination on COREG CR Drug Approval and Implications
The Food and Drug Administration (FDA, Agency, or we) has determined that COREG CR (carvedilol phosphate) extended-release capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness.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🧬FDA Classifies Inherited Nucleotide Repeat Disorder DNA Test
The Food and Drug Administration (FDA, Agency, or we) is classifying the inherited nucleotide repeat disorder DNA test 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 inherited nucleotide repeat disorder DNA test'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📞Evaluation of 988 Lifeline Program and its Business Implications
The Substance Abuse and Mental Health Services Administration (SAMHSA) requests public comment on a new data collection for evaluating the 988 Suicide and Crisis Lifeline. This initiative aims to enhance services, assess program effectiveness, and ensure better connections to crisis care. The evaluation involves various studies focusing on system-level, client-level, and impact assessments across the U.S.
Learn More📄FDA's Draft Guidance for Electronic Submission of Medical Device Q-Submissions
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Q-Submissions." FDA is issuing this draft guidance to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-subs) to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), to the current resources and associated content developed and made publicly available to support Pre-Sub electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.
Learn More📋USDA Notice to Renew Medical Examination Certification Collection
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, FSIS is announcing its intention to renew an approved information collection regarding certificates of medical examination. The approval for this information collection will expire on November 30, 2025. FSIS is making no changes to the existing information collection.
Learn More🏥Medicare and Medicaid Regulatory Corrections and Business Impacts
This document corrects technical errors in the final rule that appeared in the April 15, 2025 Federal Register, titled "Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly."
Learn More🩺FDA Classifies Plazomicin Test System as Class II Device
The Food and Drug Administration (FDA, Agency, or we) is classifying the plazomicin 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 plazomicin 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📋CMS Notice on Information Collection for Medicare Part D Electronic Prescribing
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💰Proposed Data Collection for Graduate Medical Education Program
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Learn More📄Regulatory Changes for Unaccompanied Alien Children Administration
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is inviting public comment on revisions to an approved information collection, Office of Management and Budget (OMB) #0970- 0547. The request consists of several forms that allow ORR to perform Unaccompanied Alien Children Bureau (UACB)-related administrative activities, such as facilitating stakeholder visits to care provider facilities; obtaining consent from children to share their case file information; and processing requests and waivers for the hiring of key and non-key personnel at care provider facilities.
Learn More