Page 2 - Evaluating Impact News Today

Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be...

This Week in Washington: House and Senate not in session, U.S. reaches debt-ceiling limit...

How you word and structure learner assessment questions can make the difference in whether you capture reliable, meaningful data.

On November 15, 2021, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued the fifth edition of the Agency’s guidance entitled “Policy for Coronavirus Disease-2019 Tests...

Use this process to structure and evaluate diversity, equity, and inclusion initiatives.

To embed, copy and paste the code into your website or blog: FDA has been monitoring the emergence of novel coronavirus mutations and variants and their potential for impacting the results of currently authorized COVID-19 tests.   On February 22, FDA issued a new Guidance for COVID-19 test developers entitled “Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests: Guidance for Test Developers and Food and Drug Administration Staff.” The Guidance is designed to address the sprea...

Share this article Share this article SILVER SPRING, Md., Feb. 22, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19. "The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been autho...