Federal Register Notice: FDA is making available a draft guidance for industry, Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations. It is intended to assist clinical trial sponsors in determining the amounts and types of safety data to collect in trials conducted late in developing a drug for marketing approval or after approval based on what is already known about a drug’s safety profile. The agency believes that more selective or targeted safety data collection may be possible for some late stage premarket trials and postmarket trials because certain aspects of a drug’s safety profile will be sufficiently well-established that comprehensive data collection is not needed. To download this guidance, click here. To view this notice, click here.