L’ANSM met en place un « fast-track » pour les produits innovants et dématérialise les procédures

France – L’agence du médicament lance un dispositif accéléré d’autorisation d’essais cliniques

À compter du 15 octobre, l'Agence nationale de sécurité du médicament et des produits de santé (ANSM) met en œuvre deux circuits courts, baptisés Fast Track,...
Oncologists' Off-Label Prescribing Pits Access Against Reimbursement

USA – Oncologists’ Off-Label Prescribing Pits Access Against Reimbursement

As common—and costly—as off-label prescribing is in oncology, it is poorly understood. It is, by nature, hard to study. Yet it is clear that the...
Chinese NMPA publishes UDI system rules for medical device registrants

China – China approves 17 anti-cancer drugs for medical insurance coverage

China has approved 17 anti-cancer drugs for inclusion in its national health insurance system, the government said on Wednesday, part of its efforts to...
Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) : Questions & Answers

Europe – EMA/EDQM Find Major Deviations at China Manufacturer Embroiled in Valsartan Contamination

A for-cause inspection conducted by the European Medicines Agency (EMA) and European Directorate for the Quality of Medicines and HealthCare (EDQM) found nine “major”...
NICE grants Lynparza expansion for advanced ovarian cancer

UK – XLH patients to get routine access to first new therapy in 30...

The National Institute for Health and Care Excellence has published final guidance recommending use of Kyowa Kirin’s Crysvita (burosumab) within its marketing authorisation, that...
Evaluating Reproductive Toxicity in Oncology Drugs: FDA Finalizes Guidance

USA – Complex Generic Drugs: FDA Offers Two Draft Guidances

The US Food and Drug Administration (FDA) on Tuesday unveiled one revised draft guidance and another new draft guidance to help advance the development...
Falsified Medicines Directive: Implications for parallel importers and of Brexit

Europe – Falsified Medicines Directive: Implications for parallel importers and of Brexit

Introduction to the Falsified Medicines Directive Directive 2011/62/EU, better known as “The Falsified Medicines Directive” or “FMD”, came into force on 2 January 2013, with...
The First FDA-approved Digital Pill - What It Means for Pharma

USA – The First FDA-approved Digital Pill – What It Means for Pharma

In mid-November 2017, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill...
Gilead strikes deal with NHS England on Yescarta access

UK – Gilead strikes deal with NHS England on Yescarta access

The agreement marks the first time adults will have access to CAR-T on the NHS, after NHS England reached a deal last month to...
S. Korean officials extend seasonal flu vaccine to very young children

South Korea – S. Korean officials extend seasonal flu vaccine to very young children

C Pharma (formerly known as Green Cross) has announced that it has received approval from the South Korean Ministry of Food and Drug Safety...

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