Score One For FDAAA: Uloric Approval Was Clinched By Post-Market Powers
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Within the review teams at FDA, there is the sentiment that the broadened safety authorities granted under the FDA Amendments Act allow the agency to approve drugs that it previously would have considered unapprovable, as an office director in the Center for Drug Evaluation and Research makes clear in the review documents for Takeda’s gout therapy Uloric (febuxostat).