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!
Tools for Transforming Drug Development
Introduction The FDA issued final guidance on the qualification process for Drug Development Tools (DDTS) in November 2020 after one round of revision and comments on the original draft published in 2014. With this document, titled "Qualification Process for Drug...
The CDERDirect NextGen Collaboration Portal
Rapid and secure communication with the FDA is an essential task within the regulated industry, and CDER makes some communications easier through the NextGen Collaboration portal. This tool is part of the FDA's efforts to streamline and modernize the drug development...
Uncommon Thoughts On SBIR/STTR Grants for Startup Success
SBIR/STTR grants are valuable resources for startup founders and researchers looking to fund their research and development efforts and turn their innovative ideas into successful startups. The SBIR/STTR program, which stands for Small Business Innovation Research and...
What are Some Possible Outcomes of the FDA Modernization Act of 2022?
The Impact of the FDA Modernization Act 2.0 Late in December 2022, President Biden signed H.R. 2617 (117th): Consolidated Appropriations Act into law. While boringly titled, this Act contained the FDA Modernization Act 2.0, proposed initially as S.5002. While this...
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...