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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 77
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Diversity and inclusion in oncology clinical trials

Clarify Health

OCTOBER 26, 2021

Not Enrolled Given this historical backdrop, the FDA and leading biotech and pharmaceutical manufacturers have taken initiatives to ensure: representative clinical trial recruitment that reflects the broader US patient population and equitable access to therapies and vaccines.

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Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52
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