FDA Weighs In on Non-inferiority Trial Controversy
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An FDA official responds to recent criticism about Mercks reliance on non-inferiority data to support approval of its COX-2 drug A...
FDA OKs 2 PMAs for Silicone Breast Implants
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FDA approves PMAs from Allergan (formerly Inamed) and Mentor for silicone gel-filled breast implants.