In a new draft guidance, the agency suggests that drug makers run “consumer-friendly” summaries in print ads and promotional materials
EVELYNE PIERRON's insight:
.....The “FDA believes that the brief summary should focus on the most important risk information rather than an exhaustive list of risks and that the information should be presented in a way most likely to be understood by consumers… Exhaustive lists that include even minor risks detract from, and make it difficult for, consumers to comprehend and retain information about the more important risks.”.....
An electronic repository for periodic safety update reports (PSURs) and their assessment reports is launched by the European Medicines Agency (EMA) today. The central platform was created in accordance with the pharmacovigilance legislation of the European Union (EU) and will contain all information related to PSURs in the EU. It will facilitate the assessment of PSURs by medicines regulatory authorities in the EU.
This Q&A document provides clarifications for the harmonized interpretation of the E2B(R3) IG package and should be reviewed in conjunction with the IG package. This will facilitate the implementation of the electronic transmission of Individual Case Safety Reports (ICSRs) in the ICH regions.
Ce débat sera organisé autour de six invités qui croiseront leur regard singulier sur la santé connectée et partageront leur expertise.
- Olivier Desbiey, responsable de l’innovation et de la prospective à la CNIL
- Dominique Dupagne, médecin iconoclaste du Web 2.0
- Anne Laude, doyen de l'UFR de Droit de l’Université Paris Descartes et co-directrice de l'Institut Droit et Santé
- Philippe Lemoine, président du Forum d'Action Modernités et Président de la Fondation internet nouvelle génération, auteur du rapport "La nouvelle grammaire du succès, La transformation numérique de l'économie française ".
- Alexis Normand, responsable des relations santé de Withings, société qui conçoit et produit des applications et objets connectés.
- Benoît Thieulin, président du Conseil national du Numérique et directeur fondateur de l’Agence digitale La Netscouade.
The European Medicines Agency (EMA) has made available a new tool to facilitate editing of key data fields by marketing-authorisation holders as part of the maintenance of information on authorised medicines that they have submitted to EMA.
This tool is available to users of the eXtended EudraVigilanceMedicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB).
A user manual explaining how to use this tool has been published.
Information on medicines must be updated by end of December 2014.
The European Medicines Agency (EMA) has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in its Committee for Medicinal Products for Human Use (CHMP).
Listening to patients enriches the scientific assessment of a medicine with new ways of thinking about benefit and risk from the patient perspective.
Thirty-nine medicines for human use were recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the first half of 2014, compared with 44 in first half of 2013 and 33 in first half of 2012.
The main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the Food and Drug Administration, according to a new study by a nonprofit group that tracks drug safety issues.
The study, by the Institute for Safe Medication Practices, found that only about half of reports of serious side effects submitted by manufacturers met basic standards for completeness, containing a patient’s age, sex and the date the event took place. Reports collected by the F.D.A. itself, by contrast, were found to meet those basic standards in 85 percent of cases.
The European Medicines Agency (EMA) has updated its procedural guidance on periodic safety update reports (PSURs) to simplify the way marketing authorisation holders present proposed changes to the product information of nationally authorised medicines in PSURs subject to a single assessment.
EMA will start to pilot this simplified approach in January 2015.
WEB-RADR: Recognising Adverse Drug Reactions Working together to improve pharmacovigilance through new technology Learn More
EVELYNE PIERRON's insight:
The WEB-RADR website went live on 5 December 2014 . The launch of the project website, which offers a tool to disseminate information to stakeholders about the consortium and the project aims and objectives, is part of WP5’s (project management and communication) key deliverables.
Following sustained criticism that government oversight of prescription drug safety was lacking, Canada late last week passed Vanessa’s Law, which gives the Health Minister new authority over a wide range of practices involving both the pharmaceutical industry and the national regulatory agency.
Le rapport sur la réorganisation des vigilances, commandé par Marisol Touraine à Françoise Weber, sera remis prochainement à la ministre de la Santé. Il propose notamment un portail déclaratif unique et la reconnaissance des missions de santé publique des professionnels de santé.
The European Medicines Agency (EMA) has updated its procedural guidance to ensure that marketing-authorisation holders are prepared for the submission of periodic safety update reports (PSURs) for nationally authorised medicines subject to European Union (EU) single assessment.
Letter from JAMA Internal Medicine — Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs, 1996 Through 2012
EVELYNE PIERRON's insight:
The objective of this study was to determine the frequency of premarket and postmarket boxed warnings and safety-related withdrawals for novel therapeutics approved between 1996 and 2012.
Our study demonstrates that boxed warnings are common, affecting more than one-third of recent drug approvals. While nearly three-quarters of boxed warnings had been applied to novel therapeutics at the time of approval, more than 40% acquired the warning after a median market period of 4 years.
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