Urgent Call for Comments
Deadline: 11pm EDT Sunday, Oct 31st
On September 29, 2021, the U.S. Food and Drug Administration (FDA) released a draft guidance for industry on use of electronic health records (EHR) and medical claims to support regulatory decisions on drug and biological products (download from FDA's information page here: Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biologic Products).

ISPE's Real-World Evidence Task Force's Regulatory Decision-making Subgroup has prepared comments for submission to the FDA.

Per ISPE policy 1.7.2 Circumstances of Public Importance and/or Urgency, (see Policy Manual here), ISPE's Public Policy Committee chair has agreed the urgent review of these comments.
The deadline for member comments is 11:00 pm US Eastern time on Sunday, October 31st. The comment period cannot be extended. Upon completing the review period, the authors will be provided submitted comments and, if required, prepare an updated paper for Board endorsement. The final paper will be posted to the ISPE website and shared with members.
HOW TO SUBMIT COMMENTS
Click the manuscript title above, or the button below, to open the document for comments. ISPE uses Adobe Creative Cloud for commenting. Sign-in if you have an Adobe account or continue as a Guest.

To comment, highlight the word, sentence, or section you would like to comment on and enter your comments in the box that appears on the right-hand side. You can also add sticky notes to the document using the sticky note icon from the toolbar.

If you have questions on Adobe's comment features, you can visit their help center online, or you can email us at shannon@pharmacoepi.org.
ISPE
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