In The News

April 1, 2021
To the Editor—A recent federal notice1 proposes to permanently remove oversight by the US Food and Drug Administration (FDA) over 91 medical devices, including several devices that apply artificial…
March 29, 2021
Real-world evidence, post-marketing studies, and migrating clinical trial sites into underserved communities are all strategies the U.S. Food and Drug Administration (FDA) is pushing to help increase…
March 24, 2021
Is FDA approving too many new drugs and added indications too quickly based on surrogate endpoints that fail to pan out? While patient advocates and the research community have been strong advocates…
March 23, 2021
Executive Summary After slightly more than two years as second-in-command, Abernethy tells the Pink Sheet she’s leaving FDA because the initiatives on which she was focused were starting to develop…
March 23, 2021
Executive Summary US FDA principal deputy commissioner Amy Abernethy is set to leave the agency by the end of April. The surprise news comes in the midst of the Biden administration still figuring…
March 23, 2021
Abstract Emerging retrospective and prospective studies indicate that immune checkpoint inhibitors (ICIs) can be safe and effective cancer treatments among people living with human immunodeficiency…
March 19, 2021
The global “COVID-19 Diagnostics ” Market is projected to reach USD 11.40 billion by 2027, exhibiting a CAGR of 7.9% during the forecast period. Uncontrolled spread of the coronavirus worldwide will…
March 19, 2021
Here we go again: Senator Rand Paul on Thursday faced master of reality Fauci once again. However, for some weird reason, Rand Paul failed to ask Bill Gates’ dog (you can find many references to…
March 18, 2021
Joe Biden’s pick to head the Food and Drug Administration was supposed to be an easy one. But two months into his presidency, the search for a commissioner to run a health agency critical to the…
March 17, 2021
ABSTRACT BACKGROUND: The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to…