BIO, Allergan and Roche call for FDA flexibility with patient experience data
Industry group BIO and biopharma companies Allergan and Roche are calling for the FDA to be flexible in its approach for using patient experience data (PED) and in allowing the use of such data in labeling.
BIO said that it “strongly believes” that in order for a broad adoption of PED, any upcoming guidance documents on patient-focused drug development “should emphasize the FDA’s willingness to exercise regulatory flexibility and acceptance of innovative designs and approaches for collecting PED.”
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