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Latest From Cardinal Health, Inc.

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.

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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.

United States Regulatory

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.

Regulation Generic Drugs

Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024

Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.

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