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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

Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. This approval was NOT about patients; it was about the profits of a pharma company in quicksand and sinking fast. That meeting was reportedly followed by a formal meeting between Biogen and FDA in June 2019.

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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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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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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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UK trial to test psilocin-based drug for major depressive disorder

European Pharmaceutical Review

Approval “for a Phase II study should provide us with a strong efficacy signal and expedite our pathway to approval for MSP-1014 as a new effective and more tolerable treatment for patients suffering from MDD,” added Mindset Pharma’s Chief Scientific Officer Araujo.

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