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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Reforming the World Health Organization’s Essential Medicines List: Essential but Unaffordable. Limitations on the Capability of the FDA to Advise. Value Health. JAMA Intern Med. 2022 Oct 3:e224226.

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News from the Consumer Technology Association and Withings Further Demonstrates Private Sector’s Role in the Pandemic and Public Health

Health Populi

In 2020, CES featured several hundred digital health exhibitors and a growing array of Internet of Things-connected devices adjacent to health and wellness, with representation from beyond “pure” wearable health tech ranging from FDA-cleared blood pressure watches from Omron to health insurer Humana in the exhibit hall.

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Prenosis, Roche Partner to Combat Hospital Sepsis Using Precision Diagnostics

HIT Consultant

– Building upon the collaboration that the companies started together in 2020, Prenosis will significantly expand its core NOSIS™ dataset, and the two companies will work together to obtain U.S. Food and Drug Administration (FDA) clearance for the Prenosis Sepsis Immunoscore™ and the Roche Elecsys® IL-6 Assay. Impact of Sepsis.

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My ABCovid-19 Journal – Day 4 of 5, Letters “P” through “T”

Health Populi

The “P” word was uttered by the Secretary General of the World Health Organization on March 11, confirming that the coronavirus was, technically, a pandemic. So board games and Old School jigsaw puzzles gained sales in the second quarter of 2020. P is for pandemic. R is for risk. S is for social distancing.

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How Misinformation in Health Care Can Lead to Being “Dead Wrong” — KFF and Dr. G Connect the Dots

Health Populi

health citizens of the vaccine fast-tracked to address the worst effects of the coronavirus. “Misinformation” has taken on many names: infodemic ( coined by the World Health Organization in August 2020 ), fake news, conspiracy theories, and malinformation among the monikers.

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How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Exeed Regulatory Compliance

Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. The World Health Organization (WHO) has stopped short of classifying the outbreak as a pandemic, but consistently encouraged affected countries to activate their national emergency response plans.

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

This guidance does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are described in other guidelines ( MDCG 2020-1 on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software; MDCG 2019-16 on Cybersecurity for medical devices).

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