U.S. FDA: COVID-19 Update

The U.S. FDA (Food and Drug Administration) has continuously monitored the ongoing response to the COVID-19 pandemic.  The latest update from the FDA outlines their efforts to effectively oversee and improve ongoing actions.  This update is available through an FDA news release that outlines:

• The FDA’s effort to protect consumers on the safety of drugs being marketed.
• An update on the combined actions of the FDA and Centers for Disease Control and Prevention (CDC) in monitoring the COVID-19 vaccine.
• The continual effort of the FDA to protect animals.
• Testing updates on devices that have been authorized by the FDA under emergency use authorizations (EUAs).

View the article released by the U.S. FDA at https://www.fda.gov/COVID-19 Update April 2021.

Stat One’s Response

Stat One has worked on COVID-19 related products including, diagnostic products, interventional trials, population-specific safety, and exploratory studies.  Our team is dedicated to taking a focused approach to study design and analysis based on FDA guidance for COVID-19 products.  We understand the importance of rapidly responding to the pandemic and the importance of working in a fast-paced environment.  Our statistical team prioritizes client work when necessary to provide quick and accurate analyses and responses to questions.

View Stat One’s COVID-19 experience here: COVID-19 Brochure

For more information regarding the pandemic or to speak with the Stat One team about your COVID-19 product, please contact info@statonellc.com.