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. By Aparajita Lath. This problem is not new in the biotechnology sector.

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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.

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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.

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Drug & Device Law

JANUARY 4, 2024

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. Again, the FDA does not agree.

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