Katrina’s Blog™
News and Commentary
on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.
Building the Future Bioeconomy
This month's article discusses the challenges and solutions for establishing a robust U.S. bioeconomy. The President's Executive Order on innovation in biotechnology and biomanufacturing calls for agencies to submit reports on furthering societal goals related to...
Hiring for Your Company’s Future
Photo by Ernie Journeys on Unsplash Note: I used the AI Assist Drafting in Notion to generate some topics and content blocks. As a business owner or manager, hiring the right people is crucial for the growth and success of your company. However, the tight employment...
Tools for Transforming Drug Development
Note: I used the AI Assist Drafting in Notion to generate some topics and content blocks. Photo by National Cancer Institute on Unsplash Introduction The FDA issued final guidance on the qualification process for Drug Development Tools (DDTS) in November 2020 after...
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
Note: I used the AI Assist Drafting in Notion to generate some topics and content blocks. 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...