Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
US FDA’s Reclassification Of Certain Drugs As Devices May Be 'Seismic Event' For Some
Sponsors are receiving information requests and complete response letters as a result of the agency’s transition plan, which was made in response to the Genus v. FDA ruling. The decision's aftershocks could reshape the landscape for a number of products, attorney says.
Stealth Elamipretide NDA Tests Frontiers Of US FDA’s Flexibility In Rare Diseases
FDA wants another trial in ultra-orphan Barth syndrome, but could not identify a feasible design – so Stealth submitted the NDA anyways, based on a retrospective natural history control trial