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FDA approves Analog and Dipharma’s ANDA for nitisinone capsules

Pharmaceutical Technology

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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Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

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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Pharma Marketing: A Guide for Healthcare Companies

Pharma Marketing Network

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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Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

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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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

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. The post Data integrity considerations in Pharma and Life Sciences appeared first on European Pharmaceutical Review.

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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

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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RFID: The future of smart labelling?

Pharmaceutical Technology

He adds that in the early 2000s there were no set standards for RFID in the pharma industry, so the compatibility between systems was not guaranteed. The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format.