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

European Pharmaceutical Review

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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Uri Goren

Cadensee

It might be silly question but bringing a drug to market takes many, many years. So, do you listen to them at the point when a pharma company decides what drug it needs to make? Do you listen to them to improve your marketing and the way they should take the drug or the drug should be administered and so on so forth?