FDA Law Blog
DECEMBER 2, 2024
We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. the new draft guidance and ISO 10993-1: 2018) leads to more uncertainty for sponsors.
PEMBlog
OCTOBER 18, 2024
Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. 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.
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FDA Law Blog
NOVEMBER 20, 2024
of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. It is recommended to submit a Pre-Submission to the Agency when considering your chemical characterization strategy, especially for any devices/materials with special considerations or use of alternative strategies and solvents.
Physician's Weekly
JUNE 19, 2025
On a gloomy Friday in January, Johnson, a nurse practitioner who treats older adults, had a hospice consult with Ellen, a patient in her 90s in declining health. The Health Resources and Services Administration projects a 50% increase in demand for geriatricians from 2018 to 2030, when the entire baby boom generation will be older than 65.
GeriPal
OCTOBER 10, 2024
In 2018, survey data revealed that only 41% of survey adult practices had the full complement of funded core team members, which is up from 25% of 2016. And so we often have one person go in to do the initial contact, the initial consult, and it can be anybody from any of the professions. Sometimes we all listen to the initial consult.
The Clinical Problem Solvers
FEBRUARY 8, 2023
There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. 2018 Jun;46(2):404-421. Equity in Progress: Development of Health Equity Curricula in Three Psychiatry Residency Programs.
FDA Law Blog
JUNE 10, 2025
DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.
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