Bill of Health

OCTOBER 31, 2022

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.,

COVID-19 173

COVID-19 COVID-19 Vaccine Licensing FDA 173

Bill of Health

AUGUST 29, 2022

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.

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

SQA

AUGUST 8, 2023

The rules of RDC 786/2023correspond to a normative update, which replaces RDC 302/2005. Experience with large-scale events such as Hurricane Maria and the COVID-19 pandemic, and more recent geopolitical events, have cast a wider lens on global supply chain and distribution vulnerabilities. cosmetic regulatory framework.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

AUGUST 8, 2023

The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005. Experience with large-scale events such as Hurricane Maria and the COVID-19 pandemic, and more recent geopolitical events, have cast a wider lens on global supply chain and distribution vulnerabilities. cosmetic regulatory framework.

FDA 40

FDA Compliance COVID-19 World Health 40

HIT Consultant

AUGUST 18, 2021

The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools. Here’s a look at what we’ve learned from COVID-19 era regulatory practices in clinical development. These approaches have combined to help accelerate FDA review and study commencement timelines to as low as 30 days.

COVID-19 52

COVID-19 COVID-19 Vaccine Pharmaceutical Industry FDA 52

Exeed Regulatory Compliance

MARCH 5, 2020

A novel coronavirus, now called SARS-CoV-19, was first detected in the Hubei province of China in early December 2019. There is now an FDA policy released on 29 Feb. Global outbreak of the recent novel coronavirus needs an all-hands-on-deck approach. Here is how QA/RA professionals in the medical industry can help.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

Drug & Device Law

MARCH 7, 2024

We recall that FDA was so impressed with the first published studies supporting PrEP that it asked the manufacturer of the study drugs—a three-in-one pill—to apply for the novel indication. The manufacturer of tenofovir and the original PrEP drugs also manufactures remdesivir, which has been one of the main antivirals to treat COVID-19.

COVID-19 52

COVID-19 FDA Hospitals 52