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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PharmaTech

NOVEMBER 5, 2024

In the wake of the Food and Drug Administration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever.

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Pharmaceutical Technology

MARCH 22, 2023

In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs. In recent times, various global administrators have issued regulatory standards. Why the use of RFID has fluctuated over the past decade?

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European Pharmaceutical Review

OCTOBER 19, 2022

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.

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European Pharmaceutical Review

JANUARY 9, 2024

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]. Machine Learning in Medicine.

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European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand.

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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

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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).

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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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European Pharmaceutical Review

APRIL 21, 2023

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 Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

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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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European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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European Pharmaceutical Review

MARCH 12, 2024

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. What are three current key trends in data integrity? Ensuring data integrity in the life science industry is crucial for regulatory compliance.

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Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

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Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Regulatory Compliance: Compliance with regulations must be fully understood by representatives.

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Pharma Marketing Network

OCTOBER 3, 2024

Understanding Pharmaceutical Marketing Dynamics Pharmaceutical marketing dynamics are shaped by a myriad of factors, including the rapidly evolving healthcare landscape, technological advancements, and shifting consumer expectations. It should be clear, concise, and aligned with the brand’s overall mission and values.

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Pharma Marketing Network

OCTOBER 1, 2024

By understanding these strategies, stakeholders in the pharmaceutical industry can better navigate the complexities of promoting their products effectively. Evolution of Marketing in the Pharmaceutical Industry The marketing of pharmaceutical products has undergone significant changes over the decades.

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Cadensee

JULY 20, 2021

It might be silly question but bringing a drug to market takes many, many years. So, do you listen to them at the point when a pharma company decides what drug it needs to make? Do you listen to them to improve your marketing and the way they should take the drug or the drug should be administered and so on so forth?

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Pharmaceutical Technology

MAY 16, 2023

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

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World of DTC Marketing

SEPTEMBER 28, 2020

As you all know Trump has promised a vaccine shortly before the election while Secretary Azar barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

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Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Free Webinar.

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Pharmaceutical Technology

APRIL 26, 2023

The choice of the primary packaging material for pharmaceuticals is influenced by factors such as the product’s physicochemical properties, stability, route of administration, and regulatory requirements.

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