US FDA's New Drug Assessors More Experienced With Rare Disease Issues

Now most, if not all, assessment divisions within the Office of New Drugs have dealt with issues surrounding small trials and rare diseases, defying common belief that experience was spread unequally.

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The FDA's Office of New Drugs reorganization, which includes creation of a new Office of Rare Diseases, Pediatrics and Women's Health, also remains on track. • Source: Shutterstock

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