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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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Biogen is in deep trouble and may not survive

World of DTC Marketing

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

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. Ethical leadership is essential in promoting a culture of integrity within an organisation. What are three current key trends in data integrity?

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Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

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Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

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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. We developed or explored over 100 COAs and achieved ethical approval in multiple countries including the U.S.,

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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year.