European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

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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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European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. In particular, purified water and WFI are critical when producing sterile pharmaceutical drug products. The research is focused on multiple processes, such as cleaning verification and formulation of drug products.

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PM360

OCTOBER 25, 2023

Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the pharmaceutical industry. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination.

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European Pharmaceutical Review

AUGUST 17, 2022

million of these, 2 meaning drug-resistant infections killed more people than HIV/AIDS (864,000 deaths) or malaria (643,000 deaths). Antibiotics getting into the food chain also plays a key role in the development of AMR. 2022 [cited 1 July 2022]. The staggering death toll of drug-resistant bacteria. The Lancet.

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European Pharmaceutical Review

DECEMBER 18, 2023

At the beginning of this year, EPR reported on the potential blockbuster pharmaceutical drugs to watch in 2023. Pharmaceutical manufacturing Oligonucleotides Last month, the Centre for Process Innovation (CPI) announced a new Scotland-based manufacturing facility focusing on oligonucleotide therapeutics.

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Pharmaceutical Technology

JUNE 23, 2022

US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals. As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream. There are currently ten approved continuous manufacturing applications in the US.

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