Pfizer Suffered 'Significant Loss Of Control' At McPherson Plant, US FDA Warning Letter Says
Infractions that have delayed Copaxone generic in plant Pfizer acquired when it bought Hospira suggest that pattern of quality issues may be continuing. Warning letter assigns eight tasks related to particulate contamination.
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The Quality Lowdown: ICH Q13 and Q14, Gene Therapy CMC, Drug Shortage Gaps, And An Excipient Misstep
ICH launches continuous manufacturing and analytical procedure guidelines while US FDA promises advice on gene therapy CMC, battles drug shortages and sees what went wrong with certain eye injections.
An FDA warning letter to a contract manufacturer, Pfizer, delayed Sandoz/Momenta's Glatopa 40 mg launch, reducing projected revenues and leading Momenta to consider selling assets.