Accordion 3: Dosing
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The headline about flexibility of dosing and the callout about regarding convenience of once every 3 week dosing need to be qualified. Flexibility and convenience are non-clinical claims that must be well supported by relevant evidence (section 3.1.1).
In the layout, the calendar photo isn’t consistent with dosage since the pill icon isn’t marked every day in the calendar. Image is a misrepresentation of dosage in the TMA (section 3.1). Oral dosage needs to be accompanied by the safety precautions in patients with renal impairment (section 2.4).
Supportive copy regarding orally once daily doesn’t include full dosing information for oral administration, which is also inconsistent with the TMA. The calendar also includes activities the patients can do, which can be interpreted as quality-of-life claim that requires substantiating evidence. The callout underneath regarding planning a trip is also a quality-of-life claim (section 3.1).
In the callout, the claim of saving money is a nonclinical claim that needs to be supported by evidence. The claim of time saved needs to be clarified with clearer context/evidence (section 3.1).