Bill of Health

NOVEMBER 17, 2022

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.

FDA 184

FDA World Health Medicaid Medicaid 184

HIT Consultant

OCTOBER 14, 2021

– 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.

Hospitals 98

Hospitals Electronic Medical Records COVID-19 FDA 98

Health Populi

JULY 28, 2020

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.

Public Health 116

Public Health COVID-19 Telemedicine FDA 116

Exeed Regulatory Compliance

MARCH 5, 2020

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.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

Health Populi

AUGUST 12, 2020

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.

COVID-19 93

COVID-19 Public Health FDA World Health 93

SQA

DECEMBER 16, 2022

This guidance will help applicants interpret how to implement Essential Principles of Medical Device Safety and Performance using information that was issued in March 2020. More than 6,000 comments led, quite unusually, to a second draft for renewed public comment in 2020. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

JULY 8, 2022

Note: This is a different alert to the one previously published on 23 September 2020 by the MHRA for a similar range of devices. Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40