FDA : Statement on a new effort to improve transparency and predictability for generic drug applicants

USA – FDA : Statement on a new effort to improve transparency and predictability...

The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and...
La transplantation de microbiote fécal

France – La transplantation de microbiote fécal

Quand on parle don d'organes, on imagine des organes vitaux par des donneurs brusquement décédés, des dons de reins pour des donneurs compatibles, le...
NHS prepares to fast-track ‘game changing’ cancer drugs that target genetic mutations

UK – NHS prepares to fast-track ‘game changing’ cancer drugs that target genetic mutations

The NHS is preparing to fast-track the introduction of ‘game changing’ new cancer drugs that target tumours according to their genetic make-up rather than...
Update on the EDQM review of CEP applications for sartans and next steps (June 2019)

Europe – Update on the EDQM review of CEP applications for sartans and next...

The EDQM has now finalised the review and update of the vast majority of CEP dossiers for sartans containing a tetrazole ring structure. The...
Androcur® : des patients mieux informés sur le risque de tumeur du cerveau

France – Androcur® : des patients mieux informés sur le risque de tumeur du...

Une étude publiée il y a bientôt un an révélait que l’acétate de cyprotérone, nom générique de l’Androcur du laboratoire Bayer, médicament indiqué pour combattre...
Google s’allie au français Sanofi pour développer les médicaments du futur

France – Sanofi et Google renforcent leur partenariat dans l’e-santé

Sanofi et Google réitèrent l'expérience.  Après avoir lancé en 2016 un premier partenariat dans le traitement du diabète, le géant français de la pharmacie et le...
Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure

Europe – Recommendations for the implementation of the exemptions to the labelling and package...

Following the revision of the pharmacovigilance legislation in 2012 the scope of Article 63(3) of Directive 2001/83/EC has been expanded to cases where the...
EMA activities, other than the highest priority activities (category 1 activities), that will continue in 2019.

Europe – EMA activities, other than the highest priority activities (category 1 activities), that...

EMA activities, other than the highest priority activities (category 1 activities), that will continue in 2019.
FDA approves new treatment for pediatric patients with type 2 diabetes

USA – FDA approves new treatment for pediatric patients with type 2 diabetes

The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes....
United Kingdom's withdrawal from the European Union ('Brexit')

Europe – United Kingdom’s withdrawal from the European Union (‘Brexit’)

One of the consequences of Brexit is that EMA has relocated to Amsterdam, the Netherlands, in line with Regulation (EU) 2018/1718. The Agency continues its operations in accordance with...

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