Remove COVID-19 Remove FDA Remove Informed Consent Remove Public Health
article thumbnail

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

Bill of Health

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time. million children have tested positive for COVID since the pandemic, over 3.5

COVID-19 343
article thumbnail

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

Bill of Health

Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set. The CDC, through its vaccine provider agreements, prevents physicians and parents from pursuing off-label use of COVID-19 vaccinations in young children.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

article thumbnail

Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

Bill of Health

Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated , and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19. [1]. Youth in the foster care system and those who are justice-involved face additional challenges during the ongoing COVID-19 pandemic.

article thumbnail

Health Provider News – February 10, 2023

Hall Render

over Claims Practices Where things stand in Central California 1 month after a community hospital’s closure California hospital names Kelly Linden CEO Upcoming California health bills to watch, including a conversation with Rep. billion since pandemic U.S. billion since pandemic U.S.

article thumbnail

Health Care Is Front and Center as DeSantis and Newsom Go Mano a Mano

Kaiser Health News

Front and center will be homelessness and health care, top priorities for voters — and issues that have largely defined the governors’ policies and leadership styles. From abortion to covid-19 vaccines, Newsom and DeSantis could not be further apart. California bans short-term health plans.

article thumbnail

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA 105