Bill of Health

APRIL 7, 2023

By Aparajita Lath Two articles published last month in the BMJ analyze the public investment and financing of mRNA COVID-19 vaccines, highlighting the extensive government funding that has supported the development of mRNA technology from 1985 to 2022. government. government substantially de-risking the vaccine development process.

COVID-19 Vaccine 147

COVID-19 Vaccine COVID-19 Governance Public Health 147

HIT Consultant

JULY 11, 2024

Health Sector Cybersecurity Coordination Center and the Office of Information Security, the frequency of healthcare data breaches has trended upward since 2012. Food and Drug Administration (FDA). Government Accountability Office, each medical device has an average of 6.2 According to a report from the U.S. According to the U.S.

FDA 115

FDA Hospitals Governance Ransomware 115

Bill of Health

AUGUST 4, 2024

Food and Drug Administration (FDA) , the D.C. Circuit in 2012 held that a set of FDA-proposed graphic warning labels violated the First Amendment. There is widespread disagreement among the federal courts about the types of disclosures to which Zauderer applies. Take graphic tobacco warning labels as an example. Reynolds v.

Public Health 165

Public Health FDA Governance 165

SQA

AUGUST 2, 2021

Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the United States Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in United States pharmaceutical supply chains. United States FDA – Guidances for Devices.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Kaiser Health News

JANUARY 12, 2023

On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Medicare Medicare 52

Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

FDA 52

FDA Governance 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. at 349 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance”). Medtronic, Inc. ,

FDA 59

FDA Governance Nurses Hospitals 59