Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Gain of Oversight
According to the Wall Street Journal, the Biden Administration is considering greater oversight of gain-of-function research.
US Booster Eligibility Decision
The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.
FDA Grants Emergency Use Authorization for Northeastern University SARS-CoV-2 Test
The RT-PCR-based test was developed by Northeastern University's Life Sciences Testing Center.
FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants
The agency is requiring test developers to monitor emerging mutations and their potential impact on the performance of authorized SARS-CoV-2 tests.
Booster for At-Risk
The New York Times reports that the US Food and Drug Administration has authorized a third dose of the Pfizer-BioNTech SARS-CoV-2 vaccine for people 65 and older or at increased risk.