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COVID-19 Weekly Newsletter: New Vaccine EUA Expected

Updates on vaccines for young children and a massive study on the efficacy of mask-wearing in schools headline this week’s COVID-19 news....more

COVID-19 Weekly Newsletter: “Mix-and-Match” Vaccinations Safe, Effective

This week, early findings of an NIH-backed study were released — showing that a combination of doses from any authorized vaccines is safe and effective. Meanwhile, the Department of Labor shifts focus to a traditional...more

COVID-19 Weekly Newsletter: What Do We Know About the Omicron Variant?

The Omicron variant has prompted considerable concern and uncertainty in the COVID-19 response, as public health leaders continue to advocate for vaccines and booster shots and researchers make progress in the development of...more

COVID-19 Weekly Newsletter: Additional Booster Shots Recommended as FDA Prepares to Evaluate Vaccines for Younger Children

Booster Shot Endorsements - Last week, the U.S. Food and Drug Administration (FDA) advisory committee endorsed one of the mRNA COVID-19 vaccines and the single-dose vaccine to be used as a booster shot. This week, FDA...more

COVID-19 Weekly Newsletter: Full FDA Approval

The COVID-19 vaccine approval process reached a major milestone, but the fourth U.S. wave of the COVID-19 virus has prompted some sobering projections about the future of the pandemic. COVID-19 Vaccine Receives Full FDA...more

COVID-19 Weekly Newsletter: Formidable Delta Variant Prompts Vaccine Mandates

Vaccinated Individuals Infected With Delta Variant May Carry as Much Virus as Unvaccinated - The U.S. Centers for Disease Control and Prevention (CDC) updated their mask guidance on July 27, 2021, recommending that...more

COVID-19 Weekly Newsletter: U.S. Vaccination Effort Goes International

While actively launching new initiatives and incentives to boost the vaccination rate within its own population, the U.S. government this week announced its plans to share portions of its vaccine stockpile...more

COVID-19 Weekly Newsletter: 116 Million Vaccines

It was a largely encouraging week in the U.S. COVID-19 response, where the vaccination rollout continues to outpace initial goals. Elsewhere, the World Health Organization (WHO) weighed in on the idea of requiring...more

COVID-19 Weekly Newsletter: New Vaccines, Streamlined Shipment Coordination

Addressing new variants, coordinating vaccine shipments and the continued progress of a third vaccine highlighted this week in the COVID-19 response. Vaccine Manufacturers Tackle New Variant - Manufacturers of COVID-19...more

COVID-19 Weekly Newsletter: Positive Developments in the Race for a COVID-19 Vaccine

Positive news is emerging on the vaccine front in the fight against COVID-19, as one vaccine candidate is reported to have prevented more than 90% of symptomatic infections in clinical trials, and another was granted a Fast...more

What Is Involved in Clinical Trials and What Has Changed During COVID-19: A Brief Primer

Why Do Clinical Trials? Clinical trials are an important — and government-required — step on the way from an idea to a commercial medicinal product. All new pharmaceutical and biological products and most generic...more

COVID-19 Weekly Newsletter: Vaccine Development Progresses as Cases Spike in the U.S.

There are an average of 45,000 new COVID-19 cases in the United States daily, an increase of 8% from the previous week. States that were already on an upward trajectory are getting worse and hospitalizations are on the rise,...more

COVID-19 Weekly Newsletter: Back-to-School Snags, Research Breakthroughs

Rising unemployment rates, continued deliberations on another federal relief package, and schools implementing remote learning after on-campus spikes in case rates marked an eventful week in the COVID-19 pandemic response....more

FDA Relaxes Modification Restrictions for Non-Invasive Remote Monitoring Devices During COVID-19 Public Health Emergency

On March 20, 2020, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued a new guidance document for industry and FDA staff, attempting to “help expand the availability and capability...more

FDA Issues Final Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

On March 18, the U.S. Food and Drug Administration (FDA) issued a final guidance titled FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic, providing important guidance for industry,...more

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