Forum

Your browser does not seem to support JavaScript. As a result, your viewing experience will be diminished, and you have been placed in read-only mode.

Please download a browser that supports JavaScript, or enable it if it's disabled (i.e. NoScript).

The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

580 - Hi, My question pertains to the construction of the required "Relevant warnings and precautions" section include in a fair balance section. Specifically, can the incidence of the events, for example "serious adverse events of neoplasm' or "QTc prolongation", have incidence or other clarifying information included in the fair balance section for clarification purposes so a HCP more clearly understands the context of the warnings and precautions?

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

1 Posts 1 Posters 348 Views

J Offline
J Offline
Jennifer Carroll

wrote on last edited by

#1

You may choose to include incidences. Make sure the manner in which they are included is complete, clear, and reflective of the TMA.
1 Reply Last reply

0