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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

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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Harrow agrees to acquire US rights to Novartis’ ophthalmic products

Pharmaceutical Technology

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).

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec]. N Engl J Med.

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The Role of Certified Pharmaceutical Representatives in the Shifting Sales Landscape

Pharmaceutical Representative Training

Within this dynamic sales landscape, the significance of certified pharmaceutical representatives has grown alongside the industry’s increasingly complex form and regulation. Technological advancements, shifting market dynamics, and updated regulations are leading to significant changes within the pharmaceutical industry.

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data.

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Pharma within planetary boundaries

European Pharmaceutical Review

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Giving environmental risk assessments teeth Since 2005, the authorisation of a human pharmaceutical product requires an environmental risk assessment (ERA).

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Pharma coming to moral crossroads

World of DTC Marketing

Will it lead to an early approval with limited testing or will J&J ensure the vaccine goes thru thorough testing? So the question becomes could the current administration try and approve a COVID-19 vaccine without complete testing in order to try and win votes from a public who is scared of COVID? OK, NOW WHAT?