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The Rising Tide of Medical Waste: One Model for Improvement

My Green Doctor

The breadth of services provided by modern day medicine is profound. Organizations such as EyeSustain and My Green Doctor are educating clinicians and practice managers on ways to reduce medical waste and are promoting research on this topic. The product manufacturers and vendors will need to be active partners as well.

Medical 52
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News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

FDA Law Blog

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?

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Developments in State Prescription Drug Price Transparency Laws

FDA Law Blog

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. See our previous coverage of such state laws here , here and here.) North Dakota.

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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.

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Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.