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The agency said the company failed to meet CGMP requirements, including implementing and adhering to its risk-based corrective and preventive action (CAPA) procedures

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doi:10.17226/6015

Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 4.0, DCTD, NCI, NIH, DHHS

Comment: A commenter did not believe 424.540(a)(1)'s concept of deactivating providers for non-billing enhances program integrity