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, Professional Events 17 Jan 2025 healthcare, fda, pregnancy registries, drug safety, public workshop

🏥FDA Workshop on Optimizing Pregnancy Registries

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Optimizing Pregnancy Registries." The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy. This public workshop is being held in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation program.

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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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Regulatory Compliance, Healthcare Management 17 Jan 2025 compliance, healthcare, regulation, nhsn, data collection, cdc

📊CDC Proposes New Data Collection Requirements for Healthcare Facilities

The Centers for Disease Control and Prevention (CDC), submits this Notice as a correction to the 60-day FRN (CDC Docket Number CDC- 2025-0001) published January 8, 2025 for the information collection project titled National Healthcare Safety Network (NHSN). This correction adds Polio to the NHSN package and extends the public comment period 60 days from the date of publication.

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Compliance Regulations, Employment Initiatives 17 Jan 2025 regulatory compliance, healthcare, public health, workforce development, data collection, cdc

📊CDC Notice on Proposed Data Collection for Workforce Development

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Healthcare Prevention and Response Workforce Development for Health Departments. The proposed workforce development evaluations will be used to assess whether the CDC-developed workforce development activities are reaching the intended audience and achieving the intended goal of strengthening public health workforce capacity to prevent and respond to Healthcare-Associated Infection and Antibiotic Resistance (HAI/AR) outbreaks at the individual trainee and program level.

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