Pharmaceutical Technology

DECEMBER 14, 2022

Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the Food and Drug Administration (FDA).

Food and Drug Administration 59

Food and Drug Administration Pharmaceutical products FDA Marketing 59

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 77

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 77

European Pharmaceutical Review

JANUARY 9, 2024

Adding these developments with the addition of connected IoT devices, supply chain restructuring and consideration for our code of ethics will give us a glimpse at how pharmaceutical production will look in future. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data.

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Government Pharma Ethics Training 89

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. How can these issues be addressed?

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Pharmaceutical Food and Drug Administration Transportation Manufacturing 95

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. Tony Cundell: Perhaps the second greatest challenge is the ongoing transition from products based on small molecules to large molecules to cellular therapies.

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Pharmaceutical Food and Drug Administration Manufacturing FDA 126

European Pharmaceutical Review

DECEMBER 27, 2023

Second, the production and delivery of CAR T cells necessitates close collaboration between the pharma industry and academic (usually transplant) departments. On the logistics side, the in-house process eliminates, in principle, the need for cryopreservation of the CAR T-cell products. US Food and Drug Administration.

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Manufacturing Food and Drug Administration Patients Pharma 84