The Logistics

Will FDA issue a written letter indicating that the FCN is effective?

Mar 2001

Question: Will FDA issue a written letter indicating that the FCN is effective?

Answer: Currently, FDA is sending such letters identifying the notification, including a description of the substance and any limits on its intended conditions of use, and the date on which the notification became effective.

The agency has indicated that it plans to continue providing these letters unless the administrative burden becomes too great.

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