Presidential Document 3 Feb 2025 compliance, healthcare, regulation, defense, military, labor policies

⚔️Executive Order 14183

Executive Order 14183 emphasizes the importance of maintaining high standards for military readiness and cohesion, revoking previous policies that accommodate radical gender ideologies in the Armed Forces. The order mandates updates to medical and mental health standards to ensure service members meet the rigorous requirements necessary for effective military service.

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Presidential Document 3 Feb 2025 compliance, healthcare, regulation, executive order, children, medical practices

🚫Executive Order on Funding for Gender Transition Procedures in Minors

Executive Order 14187 aims to protect children from medical interventions related to gender transition, prohibiting federal funding and promoting a policy shift in pediatric healthcare. It mandates a review of existing guidelines and outlines actions for various government departments to enforce these provisions and prioritize children's health.

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Regulatory Compliance, Industry Notification 31 Jan 2025 regulatory compliance, healthcare, pharmaceuticals, usa, controlled substances, drug enforcement

💊DEA Notice

Medi-Physics Inc. DBA GE Healthcare has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

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Compliance, Regulatory Requirements 30 Jan 2025 compliance, healthcare, regulation, drug enforcement, electronic prescriptions

⚖️DOJ Seeks Compliance on Electronic Prescriptions for Controlled Substances

The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

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Presidential Document 28 Jan 2025 energy, healthcare, regulation, housing, inflation, economic policy

🏠Emergency Price Relief Measures for American Families and Businesses

The memorandum outlines actions to provide emergency price relief for American families, targeting regulatory barriers contributing to high living costs. It emphasizes the need to reduce unnecessary regulatory burdens on housing, healthcare, and energy sectors, aiming to restore purchasing power and improve the quality of life for Americans.

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Compliance Requirements, Economic Development 23 Jan 2025 healthcare, aviation, transportation, incorporation by reference, north carolina, airspace, navigation (air), airspace regulation

✈️Class E Airspace Amendment for Kenansville, NC Effective April 2025

This action amends Class E airspace extending upward from 700 feet above the surface for Kenansville, NC, by adding airspace for ECU Health Duplin Heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

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Regulatory Compliance, Pharmaceutical Development 17 Jan 2025 compliance, healthcare, fda, drug development, oncology, chemotherapy

💊FDA Guidance on Chemotherapy-Induced Peripheral Neuropathy Available

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology." Chemotherapy-induced peripheral neuropathy (CIPN), a painful, disabling, and potentially irreversible condition commonly affecting patients receiving neurotoxic chemotherapies, could diminish survival by potentially increasing chemotherapy treatment interruptions, dose reductions, and discontinuations. This guidance provides recommendations to sponsors for the clinical development of drug and biological products intended for the prevention and treatment of CIPN in oncology patient populations.

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Compliance Regulations, Environmental Impact, Healthcare Standards 17 Jan 2025 compliance, healthcare, environmental regulations, emissions standards, ethylene oxide, sterilization
Compliance, Regulatory Requirements 17 Jan 2025 compliance, healthcare, regulations, chemicals, imports, administrative practice and procedure, reporting and recordkeeping requirements, exports, telemedicine, dea, controlled substances, prescription drugs, drug traffic control

💊New DEA Regulations on Telemedicine and Special Registration

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the "Ryan Haight Act") generally requires an in-person medical evaluation prior to the issuance of a prescription of controlled substances but provides an exception to this in-person medical evaluation requirement where the practitioner is engaged in the "practice of telemedicine" within the meaning of the Ryan Haight Act. These proposed regulatory changes would establish a Special Registration framework and authorize three types of Special Registration. This proposed rulemaking also provides for heightened prescription, recordkeeping, and reporting requirements. DEA believes such changes are necessary to effectively expand patient access to controlled substance medications via telemedicine while mitigating the risks of diversion associated with such expansion. A summary of this rule may be found at https://www.regulations.gov/docket/DEA-2023-0029.

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Regulatory Changes 17 Jan 2025 compliance, healthcare, regulations, fda, tobacco products

❌FDA Withdraws Direct Final Rule on Regulatory Hearing Provisions

The Food and Drug Administration (FDA or Agency) published in the Federal Register of September 20, 2024, a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency. The comment period closed December 4, 2024. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.

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