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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

Central Drugs Standard Control Organisation (earlier known as Drugs Controller General of India) are essential to the pharmaceutical production process. They play a crucial role in assuring the efficacy and safety of products given to patients. A company’s systems transparency may also be shown by such data.

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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

Drivers of the pyrogen testing market Increased R&D activities within the pharmaceutical and biopharmaceutical sector and a focus on biologics, were reported to hold significant growth opportunities for the pyrogen testing market. In turn, this impedes growth of the market because of the resulting delay in product approvals.

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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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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. What were the main challenges for pharmaceutical microbiology in 2022?

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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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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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RFID: The future of smart labelling?

Pharmaceutical Technology

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. In recent times, various global administrators have issued regulatory standards.