Warning Letters And Close-Outs – July 2023
The US FDA issued warning letters to three companies last month and closed out seven letters sent to companies that sold unapproved thermometers during the COVID-19 pandemic.
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Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug, the impact of a government shutdown on the agency, and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations.
Foreign tablets, active pharmaceutical ingredient residues and failed line clearance plagued operations at repackers that received FDA warning letters in FY 2023.
Litany of deficiencies, including product quality shortcomings and a failed Phase III clinical efficacy study, may make it impossible for the agency to exercise the type of flexibility it has with the approval of other treatments for ALS and neurodegenerative diseases.