Notice 30 May 2025 compliance, regulation, fda, public health, drug importation, legal consequences

🚫FDA Issues 5-Year Debarment Order Against Evan Asher Field

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Evan Asher Field for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Field was convicted of one felony count under Federal law. The factual basis supporting Mr. Field's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Field was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of April 25, 2024 (30 days after receipt of the notice), Mr. Field had not responded. Mr. Field's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

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Notice 23 May 2025 healthcare, regulations, public health, compensation, petitions, vaccine

💉National Vaccine Injury Compensation Program Petitions Received

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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Notice 22 May 2025 healthcare, nih, research, public health, advisory council, hiv

💻NIH Office of AIDS Research Advisory Council Meeting Notice

The Department of Health and Human Services announces a virtual meeting of the Office of AIDS Research Advisory Council to discuss key reports and strategic plans related to HIV research. The meeting will be accessible to the public, allowing stakeholders to participate and provide input on the agenda items.

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Notice 21 May 2025 compliance, healthcare, fda, public health, drug approval, emergency use authorization

💊FDA Revokes Emergency Use Authorizations for Specific Drug Products

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Fresenius Medical Care North America (Fresenius) for multiFiltrate PRO System and multiBic/multiPlus solutions (EUA 048), and to Baxter Healthcare Corp. (Baxter) for REGIOCIT (EUA 068). FDA revoked the Authorizations on January 16, 2025, 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.

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Notice 19 May 2025 compliance, healthcare, regulation, public health, data collection, hiv

🏥HRSA's Proposed Information Collection for HIV/AIDS Program Activities

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.

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Notice 8 May 2025 regulatory compliance, healthcare, advisory committee, fda, public health, vaccines, pandemic response, biological products

💉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.

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Presidential Document 8 May 2025 public health, policy, administration, mental health, national awareness

🧠Proclamation of National Mental Health Awareness Month 2025

The proclamation by the President recognizes May 2025 as National Mental Health Awareness Month, calling for awareness and support for individuals facing mental health challenges. It highlights the administration's commitment to improving mental health care accessibility and encourages dialogue and compassion in addressing these issues.

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Presidential Document 8 May 2025 compliance, executive order, federal funding, public health, biotechnology, gain-of-function, biological research

🧬Executive Order 14292

Executive Order 14292 focuses on improving the safety and security of biological research in the U.S. It addresses the risks associated with dangerous gain-of-function research, emphasizing the need for stricter oversight, accountability, and compliance measures to protect public health and national security while maintaining the U.S. leadership in biotechnology and health research.

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Notice 21 Apr 2025 regulatory compliance, health services, public health, vaccine compensation, federal claims

💉Overview of National Vaccine Injury Compensation Program Impact

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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Notice 17 Apr 2025 nih, health, regulatory notice, public health, meeting cancellation

❌NIMHD Meeting Cancellation Notice - April 2025

The Department of Health and Human Services has announced the cancellation of the National Institute on Minority Health and Health Disparities Special Emphasis Panel meeting originally scheduled for June 3-5, 2025. The meeting will not be rescheduled, and this notice serves as official communication regarding the cancellation.

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