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Sources2.5TB corpus

FDA Draft Guidance: Safety Reporting

Sourcep. 17

ICH E6(R3) Principles and Annex 1

Sourcep. 4

ClinicalTrials.gov Results Rule

Sourcep. 22

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1. General FDA Position and Guidance

FDA encourages sponsors to submit RWE/RWD when methods are prespecified and data quality is robust^{1 2 3}.

Submissions are strongest when analysis plans are defined before readout, comparators are clinically appropriate, and pre-specified subgroup analyses are justified with robust sensitivity checks^{4 5 6}.

FDA also weighs endpoint consistency, follow-up completeness, and protocol deviations when deciding how much evidentiary weight to assign RWE findings.

2. Examples Where RWE/RWD Was Used

Supportive evidence in rare disease contexts^{7 13 14}
Inclusion was limited when comparability was weak.
FDA cited concerns when external controls introduced residual confounding^{18 19}.

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p. 17

2.2 RWE Considerations in Labeling Decisions

FDA may consider RWE as supportive evidence when data sources are reliable and protocols are pre-specified.

In this submission, the Agency noted that external control data supported context but was not sufficient as primary evidence for efficacy claims.

Key limitations included heterogeneity in baseline disease severity, missingness in follow-up windows, and potential selection bias across cohorts.

Sponsors are encouraged to align SAPs, endpoint definitions, and sensitivity analyses with FDA feedback before final submission.

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