Katrina’s Blog™
News and Commentary
on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.
Developing Your Strategic Planning Skills
Strategy is just a fancy word for a long-term plan. Without a vision for the future and a set of choices to guide us, we often struggle to align our daily activities with our long-term desires. Fortunately, the skills needed for strategic thinking can be learned over...
Katrina’s 2022 Reading List
Once or twice a year, I like to look back through the list of books I have read and recommend a few to you. All of these are nonfiction, and several focus on personal development. I hope you enjoy them as much as I did. Reach out to me with your comments or...
What are the FDA’s Orange, Purple, and Green Books?
Among the many resources made available by the FDA, the Orange, Purple, and Green Books stand out for their names and content. These books address public demand for lower-cost drug products, which prompted laws and regulations requiring lists of alternatives.
Turnaround Time and Success Rate for Medical Device Decisions
All medical device companies need to include a success rate and time to decision for their submissions in their go-to-market plan. It turns out that helpful information on both subjects is readily available from the FDA.
The Operational Challenges Inherent to RWD/RWE
In the introduction to my June article, “FDA Guidance for Real-World Data and Evidence,” I said, “This increased activity raises questions about practical approaches to collecting and using RWD in generating RWE and concerns about patient data privacy, ownership, and informed consent.”