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STAT+: Brain biopsies on ‘vulnerable’ patients at Mount Sinai set off alarm bells at FDA, documents show

STAT

In study documents, Mount Sinai doctors said the biopsies result in “the same amount of tissue loss” and “in effect, the same level of risk” for patients as standard DBS, because they are removing tissue that would otherwise be cauterized.

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Fixing pulse oximeters requires federal might and possible legal action, researchers say

STAT

Work by device manufacturers to improve the performance of pulse oximeters on people with darker skin has progressed little since the Food and Drug Administration asked manufacturers in 2013 to voluntarily test the devices on more diverse skin tones, according to a study published Monday in JAMA.

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PDA revises report on glass container manufacturing

European Pharmaceutical Review

Having been originally published in 2007, then revised in 2013, this latest 2023 edition addresses evolving standards and container types. Specifically, the document covers the development process of glass containers for pharmaceutical products, glass container sampling as well as definition of lots.

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Ex-NHS Digital head says merger into NHS England is a mistake

pharmaphorum

In a letter to the BMJ, Kingsley Manning – who headed NHS Digital between 2013 and 2016 – said that the move is a “grave error” that could threaten the confidentiality and use of patient data. ” “NHS Digital was established to provide at least element of protection,” writes Manning.

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Building a better future for people with rare diseases in all four UK nations

pharmaphorum

Published in January, the document replaces 2013’s UK Strategy for Rare Diseases and sets out four priorities for the next five years: faster diagnosis, increasing awareness among healthcare professionals, the better coordination of care, and improving access to specialist care, treatments, and drugs.

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Teva faces EU antitrust probe over MS drug Copaxone

pharmaphorum

billion in annual sales it generated during its peak year in 2013. Copaxone (glatiramer) was once a mainstay of Teva’s portfolio with blockbuster sales that the Israel-based pharma fought hard to protect, including releasing a long-acting version to counter cheaper copycat drugs.

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Heart Failure Guideline Updates in 2021

Med Ed 101

There are a few important heart failure guideline updates in the works to the American College of Cardiology’s Heart Failure Guidelines, last published in 2013. This document […]. The post Heart Failure Guideline Updates in 2021 appeared first on Med Ed 101.