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PharmaceuticalRegulatoryProcessDrugsThePharmaceuticalRegulatoryProcess,SecondEdition(DrugsandthePharmaceuticalSciences)
by:IraR.Berry,RobertP.Martin
ByIraR.Berry,RobertP.MartinPublisher:InformaHealthCare
NumberOfPages:469
PublicationDate:2008-12-02
ISBN-10/ASIN:1420070428
ISBN-13/EAN:9781420070422
ProductDescription:ThisSecondEditionexaminesthemechanismsandmeanstoestablishregulatorycomplianceforpharmaceuticalproductsandcompanypractices.Itfocusesonmajorlegislativerevisionsthatimpactrequirementsfordrugsafetyreviews,productregulatoryapprovals,andmarketingpractices.Writtenbytopindustryprofessionals,practicingattorneys,andFDAregulators,itincludespoliciesandproceduresthatpharmaceuticalcompaniesneedtoimplementregulatorycompliancepost-approval.Newchapterscover:
