FDA Seeks Comment on Reporting Provisions In Guidance for Data Monitoring Committees

The Food and Drug Administration is seeking comments on an extension of information reporting recommendations in its guidance for clinical trial sponsors on data monitoring committees, according to a notice published in the March 27 Federal Register (80 Fed. Reg. 16,402).

The agency specifically asked for input on the effectiveness of the recommendations in the guidance and the burden the collection of information would impose.

Under the Paperwork Reduction Act, federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment.

The document, ...