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!
Breakthrough Devices Program
The final guidance for the Breakthrough Devices Program was issued by the FDA in December 2018. Under this program (part of the changes to the FD&C Act created by passage of the 21stCentury Cures Act), sponsors of devices or device-led combination products that...
Paul Gibbon’s Best Non-Fiction Books of 2018
Readers will remember my recommendation for Paul Gibbon’s book “The Science of Successful Organizational Change” from a previous post. Paul published his list of the best non-fiction books of 2018 in early January, and I believe the list deserves serious consideration...
Biomarker Qualification Evidentiary Framework Draft Guidance
The 21st Century Cures Act added a section to the FD&C Act to promote the qualification of drug development tools, including the qualification of biomarkers for use in drug development. Readers will recall my previous post on the FDA’s biomarker qualification...
CDER’s 2018 New Drug Therapy Approvals
In early January, CDER released its report on the 59 new drug therapies approved in calendar year 2018. Among the new drugs approved last year are treatments for rare diseases like phenylketonuria, the first in a new class of drugs to treat non-responding HIV-1...
The Software Pre-Certification Pilot Program Takes Another Step
Part 1 of 2The FDA has recognized that the current regulatory pathways for Software as a Medical Device (SaMD) do not let them assess the safety and effectiveness of new SaMD products at the pace of modern software development. This fact likely limits the availability...