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BioPharmaceutical

ISTA To Challenge FDA’s Refusal To Approve Bromday sNDA, Testing Little-Used Hearing Process

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Executive Summary

An unusual regulatory situation involving ISTA Pharmaceuticals’ ophthalmic drug Bromday could put FDA in the position of testing an infrequently used procedure for refusing to approve an application.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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