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GUIDANCE DOCUMENT

E19 OPTIMISATION OF SAFETY DATA COLLECTION June 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

E19 OPTIMISATION OF SAFETY DATA COLLECTION

Submit Comments by 08/26/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-13702


Docket Number:
2019-13702
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This Guideline is intended to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post- marketing studies, and how such an approach would be implemented. By collecting selective safety data,  the burden to patients would be reduced, a larger number of informative clinical studies could be carried  out with greater efficiency, studies could be conducted with greater global participation, and the public  health would be better served.