International – (CFR) 21 part 820.30 : Design verification and validation versus human factors...

In the complex world of medical device regulation, it can be difficult to keep things straight when it comes to product development. Different methods...

USA – Fauci: US won’t slow down COVID-19 testing

Dr. Anthony Fauci, the nation's top infectious disease expert, told lawmakers Tuesday that the US will be increasing coronavirus testing, saying, "we're going to be...
Levothyrox : l’ANSM publie les dernières données issues de l’enquête de pharmacovigilance

France – ANSM et COVID-19 – Demandes de visas publicitaires de DM et DMDIV

L'état d'urgence a été déclaré pour une durée de deux mois à compter du 24 mars 2020, date de publication de la loi du...

Europe – Quelle responsabilité attachée aux logiciels dispositifs médicaux ?

En matière de responsabilité juridique, les produits de santé sont principalement soumis au régime des produits défectueux. Or, les produits visés par ce régime...

USA – FDA explains COVID-19 impact on MDUFA goals, meetings

The US Food and Drug Administration (FDA) on Monday issued an immediately effective questions and answers guidance explaining the impact of the coronavirus disease...

USA – Regulatory considerations for EUA during the COVID-19 public health emergency for medical...

This article examines regulatory considerations for emergency use authorizations for medical device manufacturers in response to the COVID-19 pandemic. The authors summarize the four...

USA – FDA guidance offers statistical advice for clinical trials

The US Food and Drug Administration (FDA) on Wednesday issued immediately effective guidance offering statistical advice to clinical trial sponsors with the aim of maintaining trial...

USA – New accelerator to boost real-world COVID-19 diagnostics

A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and...

UK – Researchers develop highly sensitive blood test for cancer

The new approach could drive the development of new tests able to more accurately determine the likelihood of disease relapse and even pinprick tests...

USA – US FDA clarifies adverse event reporting requirements for medical devices designated under...

The US Food and Drug Administration has laid out adverse event reporting expectations for medical devices qualified for distribution under the agency’s Emergency Use...

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