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The Animal Rule: Testing Efficacy When Human Trials Are Not Feasible

For the vast majority of therapies, FDA requires a clear demonstration of safety and effectiveness in humans before marketing approval…

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Key Hurdles in Immuno-Oncology

Immuno-oncology is an exciting but challenging subspecialty that falls underneath the umbrella of oncology research and development. Unlike more traditional…

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Programs to Promote Drug Development for Rare Diseases

Until the early 1980s, developing therapeutics to treat rare diseases was most often a money-losing endeavor due to high cost…

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