Neuropathic Pain Second Indication Could Be Based On Single Trial – Cmte
Executive Summary
A second neuropathic pain indication could be approved based on one additional trial, providing the single trial was well-controlled and produced robust results, FDA's Anesthetic and Life Support Drugs Advisory Committee said May 16
You may also be interested in...
CDER Guidance Agenda 2004: Pregnancy, Pediatric Studies Are Priorities
FDA is planning several new guidances to refine recommendations for drug studies in children and pregnant women during 2004, the Center for Drug Evaluation & Research's guidance agenda for the coming year indicates
CDER Guidance Agenda 2004: Pregnancy, Pediatric Studies Are Priorities
FDA is planning several new guidances to refine recommendations for drug studies in children and pregnant women during 2004, the Center for Drug Evaluation & Research's guidance agenda for the coming year indicates
Neurontin Pain Claim Follows Cmte. Preference For Individual Etiologies
Pfizer's Neurontin postherpetic neuralgia indication closely follows a recent advisory committee recommendation that indications for individual etiologies of neuropathic pain would be preferable to a broad claim