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Green Practice News: April 2025

My Green Doctor

from 2000 to 2018 among people over 65 years old. It tells your office colleagues and patients that your healthcare practice or clinic is committed to forging a healthier work space and community. Encourage Small Changes That Add Up Shift your clinic toward paperless records and LED lighting to reduce waste and energy costs.

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FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

FDA Law Blog

The final guidance looks much like the prior draft and is intended to satisfy FDAs obligation to issue final guidance on consultations with persons under section 565(i) of the FD&C Act and also to provide clarity on use of third party emergency use authorization (EUA) review. Fiscal Year 2023 showed similar performance.

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Caring for Patients with Duchenne Muscular Dystrophy in the Emergency Department: A Problem-Based Approach

PEMBlog

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Always review the latest care plans, assess longitudinal trends in cardiac biomarkers, and consult with specialists when needed to ensure that each patient receives individualized and optimal care. 2018-0333I.

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PEMPix 2024 Online Case #2: Flight of Passage

PEMBlog

Pulmonology and surgery were consulted during his hospital stay, and he has since had a left lower lobectomy after healing from his pneumonia. Most patients are afebrile by the third day of treatment and clinically improved within two weeks. 2018 Jul;48(3):247-250. Epub 2018 Apr 6. Singh J, Dalal P, Rattan KN.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Exhaustive extraction in these solvents can lead to high levels of product degradation or increased levels of extractables found in the chemical data, which is not expected during clinical use, and can often result in a TRA with a negative or inconclusive outcome. KP Medical Device Consulting LLC By Adrienne R.

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Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

FDA Law Blog

The Board is not required to identify all drugs that meet the above criteria and may, in consultation with the advisory council and the commissioner of health, identify drug products that fall outside these criteria but otherwise could create “significant affordability challenges” for Minnesota’s healthcare system or Minnesota patients.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.