Skip to main content

Life Sciences

FDA Guidance on Adaptive Trials – Time To Comment!



Last week, the FDA released a new draft guidance document called Adaptive Designs for Medical Device Clinical Studies. While the title specifically calls out “medical device,” the document states the following: 

This guidance does not apply to clinical studies of combination products or codevelopment of a pharmaceutical product with an unapproved diagnostic test. However, the underlying principles may be applicable to such studies.

So, even if you’re not part of a medical device company, it’s worth your time to review this draft document. We have 90 days to submit comments that will help shape the final version of this guidance, so don’t miss your chance to voice your opinion! The deadline is Monday, August 17, 2015 11:59 PM ET.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

More from this Author

Follow Us