Archive for 2021

Special Values: "MULTIPLE" and "OTHER"

The SDTMIG directs that, under certain circumstances, variables can be populated with the values "MULTIPLE" or "OTHER". Neither of these values is what might be…

Does QNAM Need to Start with a Domain Code?

The QNAM values that appear in various examples published in the SDTMIG and TAUGs have sometimes included the domain code, and sometimes not. The SDTMIG…

The Magic that Happens between CDASH and SDTM

On occasion the mapping from CDASH to SDTM is complex. This article provides a step-by-step explanation to help follow the iteration from the CDASH example…

Coronavirus (COVID-19) Update: December 10, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On December 9, 2021,…

FDA In Brief: FDA Publishes Discussion Paper and Seeks Public Input on 3D Printing of Medical Devices at the Point of Care

The following quote is attributed to CDRH’s William Maisel, M.D.,M.P.H., director of the Office of Product Evaluation and Quality and Ed Margerrison, Ph.D., director of…

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster…

FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses

The U.S. Food and Drug Administration has a longstanding commitment to strengthening food safety and better protecting consumers, as part of its public health agenda….

Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the…

Coronavirus (COVID-19) Update: December 7, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA updated the…

FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases

The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D. “Progress in individualized medicines provides hope to patients with severely debilitating or life-threatening…