Urgent Call for Comments
Deadline: 11pm EDT Sunday, Oct 24th
On September 29, 2021, the U.S. Food and Drug Administration (FDA) released a draft guidance for industry on use of electronic health records (EHR) and medical claims to support regulatory decisions on drug and biological products (download from FDA's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 commentary on this guidance for publication in ISPE's journal, Pharmacoepidemiology & Drug Safety.

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 this commentary, titled, Assessing Feasibility of Using Electronic Health Records and Medical Claims Data for Regulatory Decisions.
The deadline for member comments is 11:00 pm US Eastern time on Sunday, October 24th. 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.
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.

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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.
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