Presidential Document 9 Apr 2025 national events, social responsibility, public awareness, healthcare, organ donation

❤️Proclamation for National Donate Life Month

This proclamation honors National Donate Life Month, recognizing the compassion of organ donors. It highlights the critical need for more registered donors and acknowledges the impact of donations on lives. The President urges Americans to consider signing up to be organ donors, emphasizing the life-saving potential of this selfless act.

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Notice 9 Apr 2025 nih, advisory council, policy discussion, public meeting, research, healthcare

🩺Notice of National Heart, Lung, and Blood Advisory Council Meeting

The Department of Health and Human Services announces a virtual meeting for the National Heart, Lung, and Blood Advisory Council. It aims to discuss program policies and issues that impact heart, lung, and blood health. The meeting is open to public attendance, with options for oral comments and presentations by interested individuals or organizations.

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Notice 9 Apr 2025 pharmaceuticals, drug regulations, fda, compliance, healthcare, market withdrawal

🚫FDA Withdraws Approval for 18 New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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Notice 9 Apr 2025 generic drugs, pharmaceuticals, fda, drug approval, flumadine, healthcare

💊FDA Confirms FLUMADINE Not Withdrawn for Safety or Effectiveness

The Food and Drug Administration (FDA, the Agency, or we) has determined that FLUMADINE (rimantadine hydrochloride) tablet, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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.

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Presidential Document 9 Apr 2025 regulation, government initiatives, medical innovation, cancer control, healthcare

🎗️Implications of Cancer Control Month 2025 for Business Owners

The proclamation for Cancer Control Month 2025 highlights the government's dedication to combating cancer through innovative research and healthcare reforms. It encourages public action to promote health and underscores the importance of preventative measures. The initiative aims to bolster healthcare infrastructure and innovation, improving treatment options for cancer patients.

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Notice 9 Apr 2025 regulations, andas, fda, drug approval, pharmaceutical, healthcare

💊FDA Finds VIBRAMYCIN Not Withdrawn, Impacts Generic Drug Market

The Food and Drug Administration (FDA, Agency, or we) has determined that VIBRAMYCIN (doxycycline) for oral suspension, equivalent (EQ) 25 milligrams (mg) base/5 milliliters (mL), was 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.

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Notice 4 Apr 2025 compliance, healthcare, grants, nih, infectious diseases, contract proposals

🏥NIH Notice of Closed Meeting on NTM Infections Review

The Department of Health and Human Services announces a closed meeting by the National Institute of Allergy and Infectious Diseases to evaluate contract proposals for developing medical interventions targeting Non-Tuberculosis Mycobacterial infections. The meeting will discuss confidential matters and will take place via video assistance. Contact information for inquiries is provided.

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Notice 4 Apr 2025 healthcare, grant opportunities, nih, advisory council, mental health

🧠Notice of National Advisory Mental Health Council Meeting

The Department of Health and Human Services announces a meeting of the National Advisory Mental Health Council focused on presenting the NIMH Director's Report and discussing various NIMH programs. The meeting will evaluate grant applications and proposals, providing insight into funding mechanisms in mental health research and services.

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Notice 2 Apr 2025 compliance, healthcare, ohio, dea, legal, medical licensing

⚖️DEA Revocation of Registration for Dr. Lager-Fermon in Ohio

The Drug Enforcement Administration issued an Order to Show Cause to Dr. Jennifer Marie Lager-Fermon, which proposed revoking her DEA registration due to the indefinite suspension of her Ohio medical license. Consequently, she is no longer authorized to prescribe controlled substances, and the Agency's findings confirmed her default following the lack of a hearing request.

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Notice 1 Apr 2025 regulatory compliance, healthcare, cms, information collection, medicare, drug pricing

💊CMS Medicare Drug Price Negotiation Program Information Collection Notice

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.

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