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FDA Postmarketing Study Oversight To Benefit From Informatics Upgrades

 
• By Sue Sutter

Changes in legacy DARRTS system, transition to new platform and standardized format for annual report submission should improve FDA's tracking of postmarketing requirements, agency tells Office of the Inspector General.

HHS OIG

FDA's oversight of drug postmarketing studies will get a boost from ongoing and planned informatics systems upgrades, a new HHS Office of the Inspector General report suggests. For sponsors, the biggest impact will likely be learning a new report submission format – and facing more scrutiny if a study falls behind schedule.

Efforts to build capacity in the agency's current drug application tracking system will make it easier to determine whether required...

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