Katrina’s Blog™
Insightful News and Commentary
On leadership, product innovation, talent cultivation, and ecosystem development across drugs, devices, diagnostics, and digital health tools.
Join us as we explore the latest trends and share expert insights to help you navigate the ever-evolving landscape of healthcare innovation.
Let’s embark on this journey of transformation together!
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...
Device Submissions Are Now All Electronic
eSubmitter Tool In December, the FDA issued a final rule revising all the regulations for medical device regulatory submissions to replace paper with electronic copies. An update to the eCopy Guidance was issued with the rule, along with updates to guidance on...
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...
Focus on Women’s Health at the FDA
Recent evidence points to an increased attention on women’s health issues at the FDA. During the FDA’s 2019 Science Forum held in September, Dr. Beverly-Lyn Cook of the National Center for Toxicological Research discussed sex and gender differences in health and...
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...