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Pharmaceuticals / Regulatory Affairs

FDA Patient Experience Data Guidance Needs Labeling Details, Drugmakers Say

Sept. 17, 2018
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In comments on the first of four FDA patient experience data guidances, Allergan and Roche urged the agency to add more details on data that can be used in labeling.

Responding to the agency’s draft guidance, Allergan said the FDA should consider making methodological requirements for gathering patient input more flexible. The drugmaker further called for the FDA to clarify the parameters of expectation around data that can be used for labeling.

“Some language suggests that there is the possibility of patient experience data collected outside of pivotal trials to be included in labeling,” Allergan noted, requesting further details on the statistical significance and replication standards the agency expects to be met.

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