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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

In turn, this impedes growth of the market because of the resulting delay in product approvals. The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor.

Safety 94
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Regulatory Compliance: Ensuring that pharmaceutical products meet all regulatory requirements and guidelines, including safety, efficacy, labelling, and post-marketing surveillance

eMediWrite

From the examination of raw materials through the release of the finished packaged product, Quality Control Authorities like Central Drugs Standard Control Organisation in India established under the Drugs & Cosmetics Act, 1940. They play a crucial role in assuring the efficacy and safety of products given to patients.

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Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder

MedCity News

The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product. Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy.

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LAMP assays to enable rapid and sensitive detection of BCC

European Pharmaceutical Review

According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3

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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products. The US Food and Drug Administration (FDA) implementation date was 7 November 2022. The post EMA publishes updated Q&A for ICH M10 appeared first on European Pharmaceutical Review.

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RFID: The future of smart labelling?

Pharmaceutical Technology

Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. 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.

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Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting.