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.

FDA words adn building icon — 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

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.

Peter Stein, director of the FDA's Office of New Drugs, who also is acting head of the OND rare disease...