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

HIT Consultant

MAY 12, 2022

While Covid-19 initially exacerbated difficulties in access, the swift public emergency declarations that led to the easing of regulations proved a catalyzer for remote models that had previously struggled to gain adoption. With increased competition, companies in the space are eyeing FDA approval as a key point of differentiation.

COVID-19 98

COVID-19 FDA Licensing 98

SQA

AUGUST 8, 2023

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. TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. cosmetic regulatory framework.

FDA 40

FDA Compliance COVID-19 World Health 40

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

Med League

NOVEMBER 23, 2022

In 2007, the US Food and Drug Administration issued a post market Alert “Carbamazepine significantly increases the risk of dangerous or even fatal skin reactions [SJS and TEN] in certain patient populations…the allele is almost exclusively found in patients with ancestry across broad areas of Asia, including South Asian Indians.”

Nurses 52

Nurses FDA COVID-19 52

Med League

NOVEMBER 23, 2022

In 2007, the US Food and Drug Administration issued a post market Alert “Carbamazepine significantly increases the risk of dangerous or even fatal skin reactions [SJS and TEN] in certain patient populations…the allele is almost exclusively found in patients with ancestry across broad areas of Asia, including South Asian Indians.”.

Nurses 52

Nurses FDA COVID-19 52