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

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

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