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Pharmacovigilance

FDA Finalizes Guidance on Postmarket Device Surveillance

The US Food and Drug Administration (FDA) on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices. The guidance comes as the Government Accountability Office (GAO) said last October that 90% of the postmarket surveillance studies FDA ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies. Most recently, FDA sent a warning letter to Israel-based Argo Medical Technologies after its failure to conduct such …

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Marisol Touraine annonce la création de Santé Publique France, l’agence nationale de santé publique

La création de l’agence nationale de santé publique, Santé Publique France, inscrite dans la loi de modernisation de notre système de santé, sera effective le 1er mai 2016. Entérinée ce jour par décret, sa création concrétise la volonté de Marisol Touraine, ministre des Affaires sociales et de la Santé, de doter notre pays d’un établissement d’expertise et de référence au service de la santé de la population. Santé Publique France reprend l’ensemble des missions, compétences et pouvoirs exercés par trois établissements publics sous tutelle du ministère des Affaires sociales et de la Santé : l’Institut national de prévention et d’éducation pour …

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Twitter, algorithme et abus de médicaments

L’augmentation des intoxications et d’abus de médicaments de prescription médicale est un vrai problème aux Etats Unis. La nature croissante de ce problème nécessite de mettre en place des stratégies de surveillance pour calculer la prévalence et les caractères de l’abus de médicaments spécifiques. C’est ainsi que les auteurs d’une étude publiée dans Drug Safety ont évalué la possibilité d’utiliser un réseau social comme Twitter, outil de surveillance et concevoir une technique de classification automatique (algorithme) permettant d’identifier des « posts » d’usage abusif de médicaments. Pour lire l’article d’Évelyne Pierron

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CFDA Restructures Medical Device Adverse Event Regulations

Following a significant revision of its framework medical device regulation (see our alert, here), the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission (“NHFPC”) have released a proposed revision to the Administrative Measures on Monitoring Medical Device Adverse Events and Re-Evaluation (“proposed Measures”), which is the primary regulation for medical device adverse events.  The proposed Measures contain the requirements for reporting, evaluating, and remediating adverse events and serious adverse events for both imported and domestically manufactured devices in China.   The comment period closed on December 20th.  We describe some of the key points of …

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FDA Faulted for Problems With Drug Tracking

Sunshine Act, Open Payments, Transparence Santé

WASHINGTON JAN. 14, 2016 Federal investigators said Thursday that there were flaws in the way the Food and Drug Administration tracked drugs after they came to market, raising questions about the agency’s effectiveness as the country’s main drug overseer. Once the agency approves a drug, it is required to monitor the drug’s safety as well as efforts by the company that makes it to study how the drug is doing in the marketplace, for example whether many patients are reporting problems while taking it. The investigators, from the Government Accountability Office, a nonpartisan investigative arm of Congress, looked at how …

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FDA details tracking of medical device ’emerging’ safety signals

The FDA just released a guidance formalizing its practice of notifying the public of “emerging signals,” or situations in which the agency is monitoring risks that have not yet been fully validated, and for which the agency does not have specific recommendations. The latest guidance appears to be inspired by that episode, and includes a list of considerations for determining when to notify the public of an “emerging signal,” as well as the template for communicating the issue. The issuance of a formal policy suggests the FDA anticipates increased communication of emerging signals as it beefs up its surveillance capabilities …

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