Quality Metrics and CMO Agreement
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
As Naheed Sayeed, Ajay Pazhayattil and Jena Spes of Apotex write, FDA’s guidances on quality agreements and quality metrics came at just the right time to address ongoing issues. Both guidances should benefit the industry, but, above all, the consumer, by establishing a framework for developing a culture of quality.
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FDA Approves Pfizer Combination Regimen for Treating R/R Diffuse Large B-Cell Lymphoma
February 14th 2025The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.
