FDA Fast Track designations reach 20th year

Twenty years after its inception, the FDA’s Fast Track designation program is going strong, with many signs that it has achieved its goal of bringing novel drugs to the market faster. Now, even with a new FDA Commissioner at the helm, the Fast Track program is unlikely to change substantially...

Three questions on indication assessment

Indication assessment ensures a clear understanding of unmet medical needs, patient segmentation, and what the therapeutic profile—efficacy, safety, dosing, etc.—needs to look like to meet those needs.
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