Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations." The guidance is intended to help sponsors determine the amounts and types of safety data to collect in late-stage premarket and postapproval clinical investigations based on what is already known about a drug's safety profile. Sponsors collect extensive safety data in clinical investigations of drug and biological products conducted to support marketing approval (premarket) and after approval (postapproval). FDA believes that selective safety data collection may be possible for some late-stage premarket and postapproval clinical investigations because certain aspects of a drug's safety profile will be sufficiently well-established and comprehensive data collection is not needed. This guidance finalizes the draft guidance issued in February 2012.