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Disease-Specific Guidances Reflect US FDA's 'Nimble, Collaborative, Patient-Focused' Approach

 
• By Brenda Sandburg

Patient groups helped with draft guidance on ALS drug development and revision of Alzheimer's draft guidance; agency also issues draft guidance on pediatric seizure, final guidances on DMD and migraine.

Guidance word in red keyboard buttons

The US FDA's five new guidances on development of drugs for neurological diseases showcase several changing aspects of the agency's regulatory approach, from how it works with patients to how it formats documents. 

"FDA recognizes the urgent need for new medical treatments for many serious conditions including neurological disorders such as muscular dystrophies, amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD), migraine and epilepsy,"...

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