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...
Medicine
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...
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.”
Resolving the Biomanufacturing Talent Shortage
I’ve been working on talent development projects since 2018. Still, this effort kicked into a higher gear in 2020 when we received a grant to develop a Bioscience Career Launch program in our regional high schools. I’ve learned much from my colleagues and...
FDA Guidance for Real World Data and Evidence
The collection and use of Real World Data (RWD) and Real World Evidence (RWE) is a hot topic of conversation. The number of commercially available mobile devices incorporating biosensors has increased dramatically since the first smartphone in 2007. The...
The eSTAR Program for 510(k) and De Novo Submissions
The FDA's electronic Submission Template and Resource (eSTAR) program currently supports medical device submissions for 510(k) clearance or De Novo evaluation. The program is voluntary, but these templates will be mandatory once the FDA publishes an adoption timeline....