ALS Drugs: A Long History Of Regulatory Twists At US FDA

The US FDA is set for two high-profile advisory committee meetings on potential ALS treatments before the end of 2022. Whatever the outcome, they will fit a pattern: when it comes to ALS treatments, there is very little about the regulatory process that feels routine.

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When it comes to ALS drugs, it is safe to say that there is no such thing as a routine regulatory review at the US Food & Drug Administration.

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