Additional training and the increased popularity of rare disease drug development in recent years appears to have overcome what was thought to be varying experience with the issue among the US Food and Drug Administration's new drug application assessors.
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.
