Fair balance
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The fair balance is required to appear in the main body copy of the email. The HCP should not be required to click or select a drop down option to view this information. If there are space limitations, middle level fair balance could be included in the main email with a link to the high level fair balance. Also, the safety information must appear in the advertising portion of the piece (i.e. prior to sign-off, legal copy, product logos).
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Regarding the high level fair balance, please revise "product Y' to fleximab. The warnings and precautions do not appear to be complete, please replace "and others" with the complete list (i.e. include immune mediate pneumonitis, immune-mediated adverse reactions). We also note that identification of the condition is non-informative. Please specify if the warning refers to patients have a pre-existing condition or a drug effect. Refer to the PAAB guidance document: Creating the three base levels of fair balance.
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