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Medical Device Legal News

This weekly news program, hosted by partner Sam Bernstein, covers recent legal and compliance developments for medical device companies, including…

United statesCity ofUnited kingdomSam bernsteinDepuy synthesUs department of justiceRadiological healthCalifornia division of occupational safetyInternational council for harmonisationWhite house office of informationNanobeak biotech incUs supreme courtWorld health organizationWhite house office of managementRegulatory affairsStar program

No More XPT Piloting New Dataset-JSON For FDA Submissions

No More XPT Piloting New Dataset-JSON For FDA Submissions
clinicalleader.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from clinicalleader.com Daily Mail and Mail on Sunday newspapers.

Sam humeSoftware tools to support datasetResource allianceProviding regulatory submissionsElectronic formatGeneral considerationsPython pandasData standards catalogDetermining whether

Podcast: Non-binding Guidance: Real-World Evidence in Drug Development

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on recent developments in FDA inspection policy, including…

United statesSarah blanksteinBeth weinmanGreg levineWorld evidence programOncology centerMarrow transplant researchInternational bloodNon binding guidanceChief counselKellie combsIm kellie combsCentury cures actCentury curesReal world evidence frameworkData standards catalog

FDA releases new guidance for drug and biological product data

FDA releases new guidance for drug and biological product data
europeanpharmaceuticalreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from europeanpharmaceuticalreview.com Daily Mail and Mail on Sunday newspapers.

Drug administrationCentury cures actFederal foodCosmetic actData standards catalog