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Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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FDA sets out its thinking on protecting children in clinical trials

pharmaphorum

The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm. ” The post FDA sets out its thinking on protecting children in clinical trials appeared first on.

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How clinical outcome assessments can help us understand the patient experience

Clarivate

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. Effective: Ensures that DSIs achieve their intended outcomes, improving clinical decision-making and patient care.

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The Future of Medical Sales Careers: Trends, Challenges, and Opportunities

Rep-Lite

From groundbreaking advancements in technology to a growing emphasis on patient-centricity, the industry is constantly evolving. In recent years, shifts in healthcare regulations, including updates in FDA guidelines and compliance standards, have significantly impacted sales representatives and healthcare providers alike.

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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. Ethical leadership is essential in promoting a culture of integrity within an organisation. What is an effective solution?

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Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Pharmaceutical Technology

However, this progress is not reflected with respect to approved treatments for paediatric IBD patients. Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients.

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