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Compliance
Compliance
FDA hits Xspray Pharma with Complete Response Letter for its leukemia candidate
The CRL relates to Good Manufacturing Practice observations at third-party manufacturer NerPharMa, and a request for additional commercial-scale consecutive batch data.
Aug. 20, 2026
Compliance
FDA classifies re-inspection of Novo Nordisk’s Indiana site as Official Action Indicated
Aug. 10, 2026
Compliance
Cellares sees FDA’s PreCheck pilot as catalyst for cell therapy manufacturing
July 9, 2026
Compliance
FDA picks seven companies for PreCheck pilot program including two CDMOs
June 30, 2026
Compliance
Novo Nordisk’s troubled Indiana site hit with Form 483 following FDA re-inspection
June 8, 2026
Compliance
FDA PreCheck pilot draws industry support as questions on execution remain
June 2, 2026
Compliance
Regulatory modernization for cell therapies: Bridging drug GMPs, tissue regulations, and innovation
June 2, 2026
Compliance
FDA announces one-day inspection pilot for low-risk facilities
May 7, 2026
Sponsored
Practical AI in GMP Asset Management: Where Life Sciences Manufacturers Can Drive Value Today
April 15, 2026
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