Answer: The ?acceptance letter? issued by FDA serves this function. FDA indicates in this letter the language that will be used by FDA, in the ?inventory of effective notifications? on the FDA Web site, to identify the substance, its intended use, and limitations.
The submitter has the opportunity to ask for changes to the description provided by FDA. In addition, if, during the course of the review, FDA modifies the coverage, FDA will notify the submitter of the changes for its consideration.
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