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Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context | Troutman Pepper

On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of.

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FDA Guidance Confirms That Multiple Roads Lead to Substantial Evidence of Effectiveness

Substantial evidence, the evidentiary standard for effectiveness established in 1962 by the US Federal Food, Drug, and Cosmetic Act (FD&C Act), is…

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Long-Awaited Guidance On FDAMA 115: Confirmatory Evidence Finally Has Its Moment (To Be Crossed Off The FDA s Guidance To-Do List) - Food and Drugs Law

This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the "single study plus confirmatory evidence" pathway.

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U S Food and Drug Administration Kicks Off Fall with Several Impactful Medical Product Guidances | Wilson Sonsini Goodrich & Rosati

The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics.

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FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
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