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FDA Warning to GSK Biologicals
FDA issued a warning letter to GlaxoSmithKline Biologicals (GSK), North America on June 12, 2014 for deviations from cCGMP requirements found during an inspection from Mar. 31 to Apr. 9, 2014 of its influenza vaccine manufacturing facility in Quebec.
FDA issued a warning letter to GlaxoSmithKline Biologicals (GSK), North America on June 12, 2014 for deviations from cCGMP requirements found during an inspection from Mar. 31 to Apr. 9, 2014 of its influenza vaccine manufacturing facility in Quebec. GSK is making progress in addressing FDA’s concerns and is working to meet supply commitments, the company said in a press release.
Problems observed included failure to assure that appropriate written procedures designed to prevent microbiological contamination of drug products are established and followed, such as validation of all aseptic and sterilization processes. FDA also observed deviations in manufacture of intermediates, including inadequate controls for the purified water system and for manufacturing processes. FDA noted that controls are inadequate to prevent bioburden and endotoxin excursions.
FDA acknowledged the company’s commitments of corrective and preventive actions. FDA said that GSK had not provided sufficient detail, however, and the agency requested a meeting with senior management.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
