FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. By Adrienne R.

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Provider Medical Manufacturing Consulting 59

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We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: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 the new draft guidance and ISO 10993-1: 2018) leads to more uncertainty for sponsors.

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Consulting Medical Management Specialization 52

PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2018 Oct;142(Suppl 2):S72-S81.

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Patients Complication Management Consulting 52

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.

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Nurse Practitioner Family Families Primary Care 52

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. They can use their training and privilege to advocate for meaningful policy reform.

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Community Patient-Centered Mental Health Board-Certified 52

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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Specialization Manufacturing Electronics PCP 69

PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Simple febrile seizures do not require neurology consults or admissions. So that’s one special population with a complex febrile seizure, even two in a 24 hour period that deserves special workup. You’re providing education and reassurance to a worried family.

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Illness Vaccination Family Families 59