Bill of Health

FEBRUARY 16, 2022

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes.

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FDA COVID-19 Vaccine Public Health COVID-19 274

Healthcare IT Today

FEBRUARY 28, 2023

COVID-19 forced a spike in policy-makers’ interest and willingness to invest in public health; a spike that is unfortunately retreating to the old business as usual. I consulted several experts in health IT to ask how such IT could improve data collection and sharing in public health.

Public Health 98

Public Health COVID-19 FDA Governance 98

HIT Consultant

MAY 9, 2022

The transition toward more digital recordkeeping in healthcare began in earnest in 2009 with the passage of the American Recovery and Reinvestment Act. If this documentation is primarily paper-based, researchers could have a difficult time ensuring each piece of documentation meets FDA standards.

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FDA COVID-19 Public Health Compliance 98

Health Populi

JANUARY 6, 2023

. “Despite breathtaking medical advancements since President Harry Truman declared war on heart disease 75 years ago, researchers have observed a disturbing trend that started in 2009: America’s death rate from heart-related conditions is climbing again,” the detailed essay explains.

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FDA Doctors COVID-19 Hospitals 104

Hall Render

APRIL 26, 2024

Vincent discord reignites after hospital revokes doctors’ privileges New Mexicans to Know: Army veteran Nancy Parson brings passion for health care to Las Cruces Army veteran Nancy Parson brings passion for health care to Las Cruces Missed deadlines lead to $11.5M

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses Hospitals 40

Drug & Device Law

MAY 11, 2023

A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. The appellate brief from FDA bears that out well.

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FDA COVID-19 Public Health World Health 59

Drug & Device Law

FEBRUARY 26, 2024

Rather, it “obligate[d] only the Secretary of Health and Human Services” to create “‘conditions designed to ensure’ informed consent.” Since the FDCA didn’t “impose any obligations” on anybody but the FDA, “it cannot conflict” with anything these defendants did or didn’t do. 555, 573 (2009), and these antivaxxers didn’t come close.

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COVID-19 COVID-19 Vaccine Informed Consent FDA 52