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Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

Bill of Health

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes , creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development. However, the act of submitting an application to the FDA based on such research (e.g.,

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How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Exeed Regulatory Compliance

A novel coronavirus, now called SARS-CoV-19, was first detected in the Hubei province of China in early December 2019. Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. There is now an FDA policy released on 29 Feb.

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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.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005. The new resolution applies to health establishments classified as laboratories and services that perform activities related to clinical analysis examinations. cosmetic regulatory framework.

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A Texas Mess

Drug & Device Law

So we do have comments on the bizarre complaint that the Texas attorney general recently filed over COVID-19. The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. FDA (8/23/21) press release (emphasis original).