FDA Actions, In Brief
Executive Summary
FDA ended the week with a flurry of activity, issuing a “complete response” letter, cancelling an advisory committee and approving several drugs.
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Regulatory News, In Brief
CDC panel recommends combined regimen of Pfizer’s Prevnar 13 and Merck’s Pneumovax 23 in immunocompromised adults; FDA issues “complete response” letters and completes review of compounded hydroxyprogesterone.
Animal Rule Studies Should Be As Well-Designed As Human Clinical Trials, Panel Says
FDA's Anti-Infective Drugs Advisory Committee unanimously said ciprofloxacin and Ortho-McNeil-Janssen Pharmaceuticals Inc.’s Levaquin (levofloxacin) had proven their efficacy for pneumonic plague in studies in African Green Monkeys, but the panel may be less willing to overlook study design flaws in less life-threatening conditions.
Accelerated Approval Could Spur Development Of Patient-Reported Outcomes Tools
A subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma was that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement.