💰NIH Meeting Notice
The Department of Health and Human Services announces closed meetings of the National Institutes of Health's Center for Scientific Review to evaluate grant applications related to addiction, cancer immunology, and Down syndrome research. The meetings emphasize confidentiality, focusing on the protection of trade secrets and personal information while providing insights into future funding opportunities in healthcare and scientific research.
Learn More💊FDA Determines RIOMET Not Withdrawn, Impacts Drug Approvals
The Food and Drug Administration (FDA or Agency) has determined that RIOMET (metformin hydrochloride) Oral Solution, 500 milligrams (mg)/5 milliliters (mL) has not been withdrawn from sale for reasons of safety or effectiveness.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 Reopens Comment Period for Good Clinical Practice Guidance
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the draft guidance for industry entitled "E6(R3) Good Clinical Practice: Annex 2," announced in the Federal Register of December 30, 2024. The Agency is taking this action to allow interested persons additional time to submit comments.
Learn More🧬NIH Notice of Closed Meetings for Grant Application Reviews
The Department of Health and Human Services announces a series of closed meetings by the National Institutes of Health to review grant applications across multiple neuroscience-related committees. These meetings will evaluate proposals while maintaining confidentiality to protect trade secrets and personal information.
Learn More🏥Request for Information on Diagnostic Excellence Measurement
The Agency for Healthcare Research and Quality (AHRQ) invites public comment in response to this Request for Information (RFI) on the development of measures of diagnostic excellence that may be calculated using administrative data or electronic health record (EHR) data. The purpose of diagnostic excellence measurement is to identify potential opportunities to improve the diagnostic process at a health system or geographic level. AHRQ welcomes comments on the importance and usability of existing measures and those that may be under development.
Learn More🚫FDA Denies Vanda's New Drug Application for HETLIOZ Insomnia Treatment
The Food and Drug Administration (FDA) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677- 012, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of insomnia characterized by difficulties with sleep initiation. The decision, which also refuses approval of sNDA 205677-012, is available in the docket identified by the number in the heading of this document.
Learn More💰Indian Health Service Loan Repayment Program
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0014, titled, "IHS Loan Repayment Program (LRP)."
Learn More🏥CDC Advisory Committee on Immunization Practices Meeting Cancelled
This is to notify the public that the February 26-28, 2025, meeting of the Advisory Committee on Immunization Practices (ACIP) was cancelled and will be rescheduled.
Learn More🏥NIH Announces Closed Meetings for Grant Evaluation Opportunities
The Department of Health and Human Services announces a series of closed meetings by the National Institutes of Health to review grant applications. These meetings, crucial for evaluating potential funding, will address various topics related to healthcare and scientific research, emphasizing the confidentiality of trade secrets and personal information involved in the grant process.
Learn More✈️Class E Airspace Amendment in Ahoskie, NC, Affects Aviation Operations
This action amends Class E airspace extending upward from 700 feet above the surface for Ahoskie, NC, by adding airspace for ECU Health Roanoke Chowan Heliport, Ahoskie, NC, to accommodate new instrument approach procedures. This action also amends the airport information for Tri-County at Henry Joyner Field Airport by updating the airport name and coordinates. Additionally, this action brings the Ahoskie Class E airspace into compliance with FAA orders. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this heliport.
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