Ionis Pharmaceuticals, Inc.
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Latest From Ionis Pharmaceuticals, Inc.
Decree imposes steps Abbott must complete before it can begin preparing to restart production, including hiring independent consultant to determine whether facility is compliant with FDA manufacturing and labeling regulations.
FDA report on inspection states Abbott and agency “found evidence" of Cronobacter species bacteria in powdered infant formula production environment and firm also identified bacteria in finished powdered formula products. Once Abbott gets FDA clearance to restart production at facility, it will need as much as two months before formula made there reaches stores.
FDA launches temporary enforcement discretion on infant formula product to help increase supply in US on same day consent decree announced to allow Abbott to restart production at facility closed since February, prompting ongoing formula shortage.
Oral or feeding tube administration of the cerebral neuroprotectant should offer flexible dosing options for amyotrophic lateral sclerosis patients, the firm says.
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