GMP: New FDA Guidance on Extent of Safety Data in Late Stage and Postapproval Clinical Investigations

On February 18, 2016, the U.S. Food and Drug Administration, FDA, published a new Guidance for Industry on \"Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations\". The guidance provides a selective approach to safety data collection during late stage premarket and postapproval clinical investigations (e.g., phase 3 clinical trials, studies of new uses, long-term outcomes) based on what is already known abaout a drug´s safety profile. FDA believes that this guidance will give sponsors the flexibility to design and implement protocols with selective safety data collection where appropriate. The guidance does not affect reporting of postmarketing adverse events relevant to an approved drug or of investigational new drug application (IND) safety information. Those reporting requirements remain unchanged.