The U.S. Food and Drug Administration (FDA) has “issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.”  …

FDA Issues Guidance on COVID-19 Vaccine Emergency Use Authorization Read more »

The U.S. Centers for Disease Control and Prevention (CDC) has updated and expanded its list of People Who Are at Increased Risk for Severe Illness for getting COVID-19.  Changes are based upon continuous detailed review of available evidence.  [For example, …

CDC Updates & Expands COVID-19 Increased Risk List Read more »

The U.S. Food and Drug Administration (FDA) Coronavirus Disease 2019 website provides a wealth of information for administrators, health care professionals and the general public.  The site includes FDA Emergency Use Authorizations, Guidance Documents & Policies, and “conservation strategies” for Personal …

Wealth of Information on FDA Coronavirus Disease 2019 Site Read more »

Keeping research skills honed is important when in class or at work.  Law Library Legal Research Seminars cover Westlaw, Lexis Advance and Bloomberg Law, as well as many topical legal research areas such as legislative history.  Several Seminars emphasize cost-effective …

Brush Up Skills with Law Library Online Legal Research Seminars Read more »

In the 3/25/2020 issue of the Federal Register, the U.S. Food and Drug Administration (FDA) announced its process for making COVID-19-related Guidance Documents available for public comment.  FDA is issuing Guidance Documents for immediate implementation without prior public comment, but …

Public Comment on FDA COVID-19-Related Guidance Documents Read more »