FDA to Finalize ALS Guidance in September

September 4, 2019

Draft guidance on the clinical development of drugs and biologics for amyotrophic lateral sclerosis (ALS) is slated to be finalized by the end of September, according to acting FDA Commissioner Ned Sharpless.

The agency issued draft guidance in February 2018 on clinical trial designs and the clinical development program for ALS drugs that target the rare disease’s neuromuscular effects. The guidance does not address in detail the development of drugs to treat other symptoms that may arise in ALS.

The draft guidance focused on specific trial design issues only encountered in ALS studies rather than defining the amount of evidence needed to support approval.

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