Archive for 2021
December 15, 2021
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…
December 15, 2021
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…
December 15, 2021
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…
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,…
December 10, 2021
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…
December 9, 2021
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…
December 9, 2021
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….
December 8, 2021
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…
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…
December 7, 2021
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…


