This guidance is intended to help sponsors determine the amount and types of safety data to collect during late-stage premarket and postapproval clinical investigations, (e.g., phase 3 clinical trials, studies of new uses, long-term outcomes). This guidance discusses a selective approach to safety data collection during late-stage premarket development or during the postapproval stage based on what is already known about a drug’s2 safety profile. This guidance provides recommendations on when to consider selective safety data collection and how to do so to maintain a balance between eliminating the collection of data that will not be useful and collecting sufficient data to allow adequate characterization of the safety profile of a drug. In addition, this guidance provides information to sponsors about consulting with the relevant FDA review division or divisions to determine whether a selective approach to safety data collection would be appropriate.
This guidance is intended to apply to safety data collection during late-stage premarket and postapproval clinical investigations in all disease settings except rare diseases. There is an existing FDA guidance that applies to the collection of clinical data in all phases of oncology clinical trials, but that guidance does not discuss selective safety data collection in the specific instances covered in this guidance. For this reason, the recommendations in this guidance may differ from those in the oncology-focused guidance. Where differences occur, the recommendations in this guidance apply.
FDA is also aware that some of the recommendations in this guidance may not align with the expectations of safety data collection in other regions or countries, which may lead to difficulty in implementing this guidance in some clinical investigations. However, we believe this guidance will give sponsors the flexibility to design and implement protocols with selective safety data collection where appropriate.
This guidance is not intended to affect reporting (as opposed to collection) of postmarketing adverse events relevant to an approved drug as required under 21 CFR 314.80 and 600.80 or affect reporting of investigational new drug application (IND) safety information as required under § 312.32 (21 CFR 312.32). Those reporting requirements remain unchanged, and selective safety data collection may only occur in a manner that would permit all regulatory reporting requirements to be fulfilled.