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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

For example, rising ambient temperatures and ingress of mould from items entering cleanrooms, has resulted in some vaccine and pharmaceutical companies in Europe experiencing increased contamination. The authors also shared: “in the last three years [since 2023], the US FDA has recalled several drugs due to fungal contamination.”

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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

The application of Bayesian methodology has been recognised by the US Food and Drug Administration (FDA) as useful in early phase clinical trials involving paediatric populations. Dr Maier has over 25 years of experience in drug development and commercialisation at pharmaceutical companies in Europe, Canada, the United States and Asia.

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Patents: a necessary evil?

European Pharmaceutical Review

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. Letter to FDA, 06 July 2022.

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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry. For example, in September 2022, the company Rebiotix, Inc.

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Amarin Makes Moves towards Global Expansion of Vazkepa

Pharmaceutical Technology

The pharmaceutical company is well on its way to achieving its goals with successful full reimbursements, already confirmed in the United Kingdom ( UK), and Sweden. GlobalData is the parent company of Pharmaceutical Technology. Following this, in 2019, the FDA approved Vazkepa for the reduction of cardiovascular risk.

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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 More FDC products flowing into pharma pipelines. The numbers tell the story.