News about "PDUFA"

FDA Publishes Guidance on Modern Statistical Methods for Clinical Research

FDA Publishes Guidance on Modern Statistical Methods for Clinical Research

The FDA guidance provides a framework for applying Bayesian analyses in clinical research, enabling data-driven assessments of safety and efficacy using both current and prior evidence.

PDUFA | 14/01/2026 | By News Bureau

Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

PDUFA | 08/08/2023 | By Sudeep Soparkar 677


 

 

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