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Newly-approved drugs have one in three chance of black box warning or withdrawal

Newly-approved drugs have one in three chance of black box warning or withdrawal

05-08-2014

Newly-approved drugs have a one in three chance of acquiring a black box warning, or being withdrawn…

Boxed warningCassie FrankPharmaceuticalPharmaceutical industryPublic CitizenRegulationUS Food and Drug AdministrationUSA

Actavis and Forest to divest four generics to gain FTC OK for merger

01-07-2014

In order for Ireland-headquartered generics major Actavis to complete its previously-announced $25 billion…

ActavisForest LaboratoriesGeneric pharmaceuticalsGenericsHealth Medical PharmaMedicinePharmaceutical industryPharmacologyRegulationUSA

EGA calls for international regulatory cooperation

03-06-2014

European Generics Medicines Association (EGA) Director General Adrian van den Hoven last week joined…

GenericsGlobalPharmaceutical industryRegulationResearch

European Commission specifies post-authorization efficacy study guidelines

European Commission specifies post-authorization efficacy study guidelines

11-04-2014

The European Commission has adopted a delegated act specifying the situations where a post-authorization…

EuropeEuropean Medicines AgencyEuropean UnionPharmaceuticalPharmaceutical industryPharmaceutical sciencesPharmacologyRegulationResearch

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