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Lights, Camera, Goal Dates: Pharma Gets Going With ANDA Suitability Petitions

 
• By Anju Ghangurde

Sponsors return with US suitability petition submissions against the backdrop of GDUFA III new goals for the FDA's response to such petitions. Scrip tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

US FDA enhances processes for review of suitability petitions • Source: Shutterstock

Goal dates and enhanced regulatory review processes appear to have invigorated sponsors, including leading Indian pharma firms, to file or refile suitability petitions in the US, reviving a strategic front that addresses market gaps without the need for new clinical data.

Nimish Mehta, founder of the pharma-focused Indian business analytics firm Research Delta Advisors, told Scrip that the surge in suitability petitions (SPs) could be ascribed to the change in guidelines as the US Food and Drug Administration works towards new

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