FDA Releases Draft Guidance for Industry on Safety Data Collection
The US Food and Drug Administration (FDA) released new draft guidance for industry entitled Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations on 9 February.
The document provides guidance on how to determine the amounts and types of safety data to collect in trials conducted late in the premarketing process or after a product's approval.
The guidance will also allow sponsors of clinical trials to target the collection of safety data more specifically, as FDA believes that "certain aspects of a drug's safety profile will be sufficiently well-established that comprehensive data collection is not needed."
- FDA - Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations; Availability
- Guidance for Industry Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations