Outdated Regulatory System Slows Technical Progress, Investigator Charges

 
• By Shirley Haley

Allowing other stem cell companies to use the protocol honed by Neuralstem instead of starting at square one would speed promising therapies to ALS patients and advance the field, researchers and patient advocates argued at FDA’s hearing on ALS drug development and regulation.

FDA should loosen its grip on procedures when it comes to similar investigational stem cell therapies and allow companies coming up to follow protocols already refined by researchers testing new technologies, a lead investigator on the Neuralstem Inc. trial argued at a Feb. 25 public hearing. FDA convened the meeting to get stakeholder input on the development and regulation of therapies for amyotrophic lateral sclerosis.

The regulatory process is presenting barriers based on a very traditional model of drug development that should be updated and...

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