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Pharmacovigilance

Senate report says FDA fails to ensure medical devices are safe

Pharma Compliance Info Senate report says FDA fails to ensure medical devices are safe Pharmacovigilance

America’s system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs, according to a Senate investigation released Wednesday. The report, from Sen. Patty Murray, a Washington Democrat, blames device manufacturers, hospitals, and the Food and Drug Administration for infections that sickened at least 250 people worldwide since 2012 and that may have contributed to dozens of deaths. The series of outbreaks went on for years before safety problems with the endoscopes came to light in the media in 2015. The report says the events expose systemic weaknesses in the FDA’s approach …

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How pharma companies are using social media to learn about drugs’ affects on patients

Pharma Compliance Info How pharma companies are using social media to learn about drugs' affects on patients Pharmacovigilance

In an attempt to gain more health information, United Kingdom-based pharmaceutical company GlaxoSmithKline has begun collecting data from social media sites such as Facebook and Twitter that mention any of a company’s 1,000 different drugs. In its partnership with United States-based informatics company Epidemico, the two found over six million Twitter mentions and more than 15 million Facebook hits. Epidemico assists GSK in filtering the data, getting rid of irrelevant posts and standardizing the language around complex drug names and medical conditions. To read the article by Eric Harding

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Social media and pharmacovigilance: A review of the opportunities and challenges

Pharma Compliance Info Social media and pharmacovigilance: A review of the opportunities and challenges Pharmacovigilance

Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions. To read the article by the British Journal of Clinical Pharmacology

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Dr GOOGLE , promu lanceur d’alerte par la FDA

Pharma Compliance Info Dr GOOGLE , promu lanceur d’alerte par la FDA Pharmacovigilance

L’information n’est pas passée inaperçue sur les réseaux sociaux à propos du moteur de recherche Google qui pourrait aider l’agence américaine du médicament (FDA) à détecter les effets secondaires des médicaments. Le Figaro Web &Tech y voit de l’espionnage mais ne s’agit-il pas plutôt d’un pas de plus vers l’hégémonie de l’algorithme, de l’usage des métadonnées pour une meilleure utilisation des signaux en pharmacovigilance ? Pour lire l’article d’Evelyne Pierron Pour lire l’article de Bloomberg

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