On November 5th, CDRH will host an Industry Basics Workshop on 513(g) request for information regarding the classification of a medical device. The session will be immediately followed by another on exemptions for custom devices to address unique patient or physician...
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Electronic Regulatory Submissions Part 4
Stay Current on Guidance When Planning Your Submissions (Note: This post is part of a multi-part series on the CTD this fall) In my last post in the series we reviewed what we could find on the history of a main eCTD guidance. There are a fair number of eCTD related...
Guidance on Clinical Bioanalysis
Q&A on Evaluating Internal Standard Response In September, the CDER issued a level 2 guidance containing a series of questions and answers on the evaluation of internal standard responses during bioanalysis of clinical trial samples. Normally used in...
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...