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In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.
Additional studies have shown an ultra-high dose of mecobalamin safely decreased ALS progression in early-stage patients by 43%. Japan has spent decades studying the drug’s efficacy for the disease.
Industry comments also seek more specificity on the types of real-world data that could supplement a single adequate and well-controlled trial to demonstrate substantial evidence of efficacy, and clarification as to whether confirmatory evidence can come from the same single clinical study.
Highly negative FDA advisory committee review and subsequent discussions with the agency made clear the only path forward was a new study, company executives said. Troubled application shows the limits of FDA’s willingness to exercise regulatory flexibility.
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