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FDA should consider allowing sponsors in challenging area of single species antibacterials more flexibility in study designs, advisory committee suggests, despite disagreement over approaches such as animal models and non-inferiority trials.
Payers and prescribers, not just the US FDA, need to understand the basis of approval, John Rex says.
Sponsors lack comprehensive advice on how to access benefits of GAIN legislation's incentives, which include the opportunity for fast track designation, priority review designation and five years of market exclusivity, government watchdog says.
Recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
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