March 2024 marks four years since the coronavirus outbreak and the global pandemic lockdown started. I wrote several articles spanning February – April 2020, sharing information and making some projections. This is a good time to reflect on the past and what we’ve...
COVID
Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)
Chapter 14 - FDA’s Coronavirus Treatment Acceleration Program (CTAP) Recognizing the need for rapid COVID-19 pandemic response, the FDA has created the Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as quickly as possible while...
Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)
Chapter 13 - NIH Foundation is Coordinating a Global Research Effort This month, NIH launched a public-private partnership to develop an international strategy for the research on the COVID-19 pandemic. Part of the “part of the whole-of-government, whole-of-America...
Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)
Chapter 12 - Quarantine Reading List - Leadership It's clear we will need innovation and leadership to overcome the health and economic challenges posed by the pandemic to our businesses and community. While you are staying home to stay healthy, make a change to your...
Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)
Chapter 11 – CDER Creates a Single Site for Its COVID-19 Response Activities So much new information is being released daily by the FDA in response to the COVID-19 outbreak that it can be hard to keep track of the latest developments or current guidance. Some...
Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)
Chapter 10 – Are Your Clinical Trials Impacted by COVID-19? Because I spend a lot of time thinking about the approval process for new medical products, I had already begun to consider the impact of travel and access restrictions on the conduct of clinical trials....
Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)
Chapter 9 – Preparing for an Epidemic Here’s a Ted Talk from 2015 by Bill Gates which presents a strikingly (though not surprisingly) prescient look at the ‘next epidemic’. What I like best about this talk are the preparedness ideas he presents. I’ve already...
Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)
Chapter 8 - More Immediate Actions by the FDA to Increase Medical Supplies The COVID-19 outbreak has created shortages of medical supplies such as gloves, masks, hand sanitizer, and respiratory ventilators (the last essential for treatment of critical care patients)....