Thursday, 27 January 2022

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Thursday, 27 January 2022

Off-label could become official

Posted 9 February 2021 AM

The TGA is conducting a public consultation that seeks "to understand potential obstacles and incentives to repurposing of prescription medicines that may influence a company's decision to extend an indication" for an existing medicine previously registered in Australia.

It hopes to hear from sponsors that wish to extend indications for an existing medicine either already approved overseas for the indication, for a less common disease, already accepted clinical practice albeit "off-label", or likely to be less commercially profitable.

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