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...
Science
The FDA’s Approach to DHT is Evolving
The FDA’s thinking on Digital Health Technologies (DHT) continues to evolve. They released the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development in March. This publication, a PDUFA VII commitment, will “guide activities...
What is Pharmaceutical Advanced Manufacturing?
Pharmaceutical manufacturing has traditionally been a batch-based process, with different stages of production being conducted in discrete steps. However, in recent years there has been an increasing interest in continuous manufacturing as an alternative to...
University of Washington Biomedical Regulatory Affairs Masters Degree
Here’s my CMC lecture for the 2023 University of Washington Biomedical Regulatory Affairs Masters Degree graduating class. In it, she explains how companies that produce drugs, biologics, and medical devices develop, validate, and operate processes that ensure the...
Evergreen Bioscience Innivation Cluster Presentation to WSU ETM575 Class
I always love talking with students. A few weeks ago, I had the opportunity to share the Evergreen Bioscience Innovation Cluster with students in the Washington State University EM575 class. https://youtu.be/wDgmCPSiw_g
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.”