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US legislative update: takeaways for European pharma

European Pharmaceutical Review

The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 3) policing anticompetitive settlements between competing drug manufacturers. 3) policing anticompetitive settlements between competing drug manufacturers. 5) monitoring access to biosimilars.

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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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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines. The captured carbon is then transformed into high-value organic chemicals that can then be used as feedstock for product manufacturing. Carbon capture and utilisation (CCU).