International – COVID-19: Daily Report for Life Sciences and Health Care Companies

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in...
Les Organoïdes supplantent désormais les méthodes In Silico dans la R&D

International – Le In Silico bientôt supplanté par les Organoïdes

Les recherches in silico (néologisme qui aurait été inventé en 1989) ont pour but de produire et présélectionner les médicaments potentiels ; elles ont le pouvoir d'accélérer...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – ISO 14971 : 2019 – GAP-ANALYSIS résumé versus l’ancienne version ISO EN...

  Cliquez ici pour accéder au résumé Nous contacter pour la version complète.  
WHO drafts guidance for pharma supply chain tracking

International – WHO publishes its draft Policy brief on traceability of health products for...

In the context of the 2030 target for UHC for all, the World Health Organization recognizes that traceability systems and technologies could be leveraged...
Saudi FDA extends GHAD deadlines, issues guidance documents

Saudi Arabia – Saudi FDA extends GHAD deadlines, issues guidance documents

With the Saudi Food and Drug Administration (SFDA) in the process of implementing a new regulatory system, medical device manufacturers active in Saudi Arabia will...
DM et Phtalates

International – DM et Phtalates

Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR)...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – Improving Biosecurity with first International Standard for Biorisk Management

SARS, pandemic viruses and threats of the malicious use of pathogens have all woken the world up to the risks of biological materials and...
Unique Device Identification and Recall Management: Starting with the Patient in Mind

International – Unique Device Identification and Recall Management: Starting with the Patient in Mind

This article provides an overview of FDA’s medical device Unique Device Identification System Final Rule and explains why including UDIs in health information and in...
WHO drafts guidance for pharma supply chain tracking

International – WHO Drafts Policy on Designating Regulators as Listed Authorities

With an eye toward strengthening the regulation of medical products in underserved regions, the World Health Organization (WHO) late last year published a draft...
2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming in 2020

International – 2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming...

As 2019 comes to a close, Focus takes a look back at what articles received the most attention as well as what to expect for the...