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!
Strategic Planning for Medical Products
Part 1 - US Pharmaceutical Regulatory PathPharmaceuticals and medical devices are regulated in the USA by the FDA. The regulations started to diverge in 1976 following the passage of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. Each type of...
I’m Excited by This Year’s Nobel Laureates in Science & Medicine
The winners of the Nobel Prizes are announced in October each year, and this year’s science Prizes represent significant advances in our knowledge. I’m super excited by this year’s Nobel prize in Chemistry, given to Jennifer Doudna and Maxine Charpentier for their...
Medical Device Development
Part 1 – Medical Device DesignJune is our month to examine how new medical devices are approved. In this 4-part series we’ll focus on FDA regulatory pathways, although much of what we discuss can be applied in other jurisdictions. Global harmonization of device...
New Medicine Development
Part 1 - DiscoveryMay is our month to review how new medicines are developed. This will be an eight part series describing the different stages of drug development which are applicable in all regulatory jurisdictions.The aim of discovery research is to clearly...
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...