FDA pilots cross-functional teams to expedite product review process

Recognizing an “urgent need for new medical treatments” for many neurological disorders, the US Food and Drug Administration says it's revising its product review team structure and changing the way it communicates scientific and regulatory guidance.

In a statement, FDA Commissioner Scott Gottlieb says the agency is “modernizing multiple aspects of its drug regulatory programs,” in an effort to promote development of new therapies for diseases such as muscular dystrophies, amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), migraine and epilepsy.

The agency will “move away from a more siloed structure,” and adopt instead a cross-functional, team-based approach to the medical product review process.