485 - If there are updates to safety information, is there a grace period that PAAB allows before pieces have to be updated with the new label?

Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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  • Jennifer Carroll

    Safety information in advertising must reflect the current product label so as not to contravene section 9.1 of the Food and Drugs Act. There is no formal “grace period” per se. It would behoove manufacturers to take action in a manner which demonstrates prompt re-alignment of advertising to the TMA. Patient safety is paramount.

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