United States:
FDA Announces Intent To Review Study Data Reviewer's Guide Template
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In the July 23, 2015, Federal Register, FDA
and the Center for Drug Evaluation and Research announced the
establishment of a public docket to collect comments related to a
proposed Study Data Reviewer's Guide template. The purpose of
the review is to determine whether FDA will recommend its use
either as is, or in a modified form, for regulatory submissions of
data. Comments are due September 21,
2015.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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