FDA released this week a Guidance on Postmarketing Approaches to Obtain Data on Populations under represented in Clinical Trials
Pierre Mermet-Bouvier
![Pierre Mermet-Bouvier]()
Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
This week, FDA released a Draft Guidance for Industry, "Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials".
The 11-page document can be downloaded at: https://www.fda.gov/media/170899/download
Interestingly, it was not part of the list of expected Draft Guidances this year, on CDER agenda.
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