Katrina’s Blog™
Insightful News and Commentary
On leadership, product innovation, talent cultivation, and ecosystem development across drugs, devices, diagnostics, and digital health tools.
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Electronic Regulatory Submissions Part 3
What’s the Current eCTD Guidance? (Note: This post is part of a multi-part series on the CTD this fall) In my previous post, we reviewed the types of submissions for which the FDA requires eCTD format. One of the earliest guidance for eCTD still available was issued...
The FDA’s Clinical Outcomes Assessment Compendium
Are you planning the clinical phase for your new therapy and wondering what measures of clinical outcomes have been used successfully for other drugs or biologics? One place to start your research could be the FDA’s Clinical Outcomes Assessments Compendium, which...
Electronic Regulatory Submissions Part 2
What has to be submitted electronically? (Note: This post is part of a multi-part series on the CTD this fall) The eCTD guidance is one of the very few that specify requirements for applicants; most include a statement that the guidance represents the agency’s current...
Spokane’s Steve Gleason Institute for Neuroscience
In early 2019, Washington State University Health Sciences Spokane announced the formation of the Steve Gleason Institute for Neurodegeneration. Dedicated to the development of effective treatment strategies for neurodegenerative diseases such as Amyotrophic Lateral...
Electronic Regulatory Submissions Part 1
What is the Electronic Common Technical Document? (Note: This post is part of a multi-part series on the CTD this fall) Since 2017/2018, CDER and CBER have required all applications, amendments, supplements, and reports be submitted electronically using the Electronic...