ANDA Suitability Petitions: The Timelines They Are A-Changin'

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

US FDA enhancing processes for reviewing suitability petitions • Source: Shutterstock

US suitability petitions may be seeing renewed interest from sponsors following a surge of filings after the introduction of goal dates in October and then a drop-off of submissions after that.

Nimish Mehta, founder of the pharma-focused Indian business analytics firm Research Delta Advisors, told Generics Bulletin sister publication the Pink Sheet that the surge in suitability petitions (SPs) could be ascribed to the change in FDA guidelines as the US Food and Drug Administration works

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