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

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. References Warning Letters.

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Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

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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. Between May 1, 2016, and May 31, 2021, 42% of all U.S. Certain markets (e.g., References: 1. 3 (2022): e222265.

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

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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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