Remove FDA Remove Informed Consent Remove Public Health
article thumbnail

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1

Bill of Health

Food and Drug Administration or FDA), which contributes to the development of knowledge about the unapproved product’s safety. However, EUAs are limited to public health emergencies, and RTT is only rarely used, so we concentrate here on EA, which is used by thousands of U.S. patients each year.

FDA 237
article thumbnail

AI’s Ability to Manipulate Decision Making Requires a Moratorium on Its Use in Obtaining Consent for Biomedical Research

Bill of Health

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S In 2017, Congress acted again to update the Common Rule and strengthen the provisions related to consent. While the U.S. These warnings echo those of the U.S.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

Bill of Health

Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time. Up until a few days before, the public was expecting approval to possibly drag into summer. Doctors and parents used the group to collectively make public calls to agencies like the FDA and U.S. Solutions for the Future.

COVID-19 344
article thumbnail

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

Bill of Health

Jonathan Perez-Reyzin is a law student at Yale Law School interested in health justice, criminal law, and the intersection of law and philosophy. Justin is currently engaged in clinical work seeking to expand the reach of harm reduction services in New Haven.

FDA 147
article thumbnail

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

Bill of Health

Food and Drug Administration (FDA)-approved product for a different population, use or dosage than it was approved for, is very common in medicine. It also runs counter to our approach on other cutting-edge questions regarding the implementation of COVID-19 vaccinations, such as their use in pregnant women or mix-and-match boosters.

article thumbnail

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

Bill of Health

By Victoria Kalumbi. 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].

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.