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.

Management 76

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 76

European Pharmaceutical Review

NOVEMBER 8, 2022

3) policing anticompetitive settlements between competing drug manufacturers. European pharmaceutical companies targeting the US market should be aware of these pending bills and their potential impacts on market entry, intellectual property enforcement and payer access. 5) monitoring access to biosimilars.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

European Pharmaceutical Review

DECEMBER 21, 2022

The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines. Organic compounds are arguably the foundation of the pharmaceutical industry. Defossilisation of pharmaceutical supply chains has only recently been assessed for the first time.9

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Manufacturing Pharmaceutical Healthcare Healthcare 74