ANSM: National Security Agency of Medicines (Agence Nationale de Securite du Medicament), which is set to replaces AFSSAPS
(46) While AFSSAPS
drew similar conclusions, mechanical testing of the breast implant shell confirmed a potential increased risk of rupture.
It seems also credible that the recent decision of the AFSSAPS
to review the risk/benefit ratio of the Vastarel (another drug marketed by Servier in 1965) is related to the Mediator issue.
The 175-page AFSSAPS
report was released yesterday.
Ethical approval was obtained from the University of Nice scientific and ethics review committee (CPP Sud Mediterannee V) and from the appropriate local and government agencies including the Agence Francaise de Securite SAnitaire des Produits de Sante (AFSSAPS
On peut encore citer la Commission de securite virale ou la Commission de therapie genique, dependantes toutes deux de l'Agence francaise de securite sanitaire des produits de sante (AFSSAPS
Jacques Le Bras, PhD, has disclosed the following relevant financial relationships: received grants for clinical research from GlaxoSmithKline; received grant from GlaxoSmithKline on application of AFSSAPS
phase 4 requirement on Malarone.
This work was supported by grants from INSERM, the Fondation de France, the Association pour la Recherche sur 1c Cancer (ARC), the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS
), the Agence Francaise de Securite Sanitaire de l'Environnement et du Travail (AFSSET), the association Cent pour sang la vie, the Institut National du Cancer (INCa), and the Institut de Veille Sanitaire (InVS).
Capsugel (www.capsugel.com) has received authorization from AFSSAPS
(the Agence Frangaise de Securite Sanitaire des Produits de Sante) to produce clinical batches at its Product Development Center in Strasbourg, France.
The Clinical Pharmacology Unit carries out Bioequivalence studies meeting international regulatory requirements like USFDA (USA), ANVISA (Brazil), AFSSAPS
(France) and WHO (World Health Organization, Geneva) and has successfully cleared their audits.
As it turns out, the United Kingdom Competent Authority, Medicines and Healthcare products Regulatory Agency and the France Competent Authority, Afssaps
, view breast pumps that are solely intended to collect milk from the mother for feeding to the baby as a general-purpose consumer good--and, thus, not with the purview of the medical devices directive.
Additional data on isobutylparaben were requested in order for AFSSAPS
to be able to give this ingredient a clean bill of health."