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@Agency and @Manufacturer

The PAAB has posted a new guidance on study durations as a results of our global benchmarking initiative and based on industry consultation. Please see the Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising and post any questions you have regarding this document, below.

Please note that this guidance will go into effect April 18th. PAAB will not be accepting submissions with updated data prior to this date to ensure all companies have sufficient time to assess the changes.

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Expanding the approach to exclusivity claims

@Agency and @Manufacturer A new advisory has been posted on Exclusivity Claims for Indications. If you have any questions, please post below:

Please leave questions on this guidance below:

Please share your comments and questions below. The full article can be found here

As well as some Examples