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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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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. How can this be mitigated?

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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

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. We developed or explored over 100 COAs and achieved ethical approval in multiple countries including the U.S., All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

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Hope in sight with Apellis’ pegcetacoplan OAKS/DERBY results for GA

pharmaphorum

So, really,” he continued, “[there are] three major take-homes to talk about: first efficacy, then function, and then safety. Additionally,] in my opinion probably the most important safety angle to consider is rates of wet AMD [age-related macular degeneration] were increased with pegcetacoplan treatment, that is 12.2%, 6.7%, and 3.1%

Safety 103
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Challenges in the Medical Sales Industry

MedReps

There’s no shortage of challenges for those new to pharma, medical sales and even veterans. First, they’ll likely have more interest in learning about what you sell and second, they’ll be more hesitant to try it because of concerns about insurance coverage, efficacy and safety. Competitors and Generic Medications.