Three Orphan Drug Program problems and how the FDA plans to fix them

When the FDA bestows an “orphan” designation, it validates a product’s potential benefit. However, sponsors can pursue and receive an orphan designation for a pediatric population which waives Pediatric Research Equity Act (PREA) requirements and exempts the product from clinical studies in a pediatric population.
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Is medical institution M&A squeezing out clinical research?

The biggest impact of the consolidation among academic research and healthcare organizations for the biopharmaceutical industry could occur if a for-profit mentality diminishes an academic institution’s emphasis on basic science and translational research, Laurie Halloran, president and CEO of Halloran Consulting Group, told Scrip.
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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...
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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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