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Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

FDA Law Blog

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. The classification order identifies the special controls and therefore is extremely important.

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Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law Blog

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. In Section I.A,

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Hastening Death by Stopping Eating and Drinking: Hope Wechkin, Thaddeus Pope, & Josh Briscoe

GeriPal

And is there a middle path to provide some degree of comfort while also hastening the end of life? Should these patients qualify for medical aid in dying medications? Eric 00:13 And Alex, who do you have with us today? Alex 00:14 We have a very full house today. Hope Wechkin brought this topic to us. We love it when our guests suggest things.

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Optimizing Nutrition in Aging: A Podcast with Anna Pleet, Elizabeth Eckstrom, and Emily Johnston

GeriPal

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. In memoriam.

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