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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.
Intercept pharms inc
Drug administration
Hemispherix biopharma inc
New drug application
Drug omnibus report act
Not withdraw accelerated approval most
Malignant hematological
Draft guidance
Demonstrating substantial evidence
Human drug
Biological products
Peter marks
Final decision
Withdraw approval
Providing submissions
Non electronic format
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