Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions
This guidance is intended to assist sponsors who will be submitting information to the Clinical Trials Data Bank. The data bank was established as required under section 113 of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). This guidance combines the statutory and procedural issues discussed in two previously published draft guidances on this topic. It was finalized after considering comments received on the two draft guidances.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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 comments should be identified with the title of the guidance.