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Policies & Guidance

Seeking Opinion from FDA Regarding Drug Exemption

Below is suggested template language to utilize when seeking an opinion from the FDA regarding drug exemption.

Please note this does not replace the IND process, but is only intended for use when contacting the FDA for an opinion regarding potential exempt status.

Three paper copies of this inquiry should be mailed to:

For drug products, including biological therapeutics, write or call:

Drug Information Branch
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 2201
Silver Spring, Maryland 20993-0002

(Phone) 301-796-3400

For further information regarding drug and device development, please contact the Indiana Clinical Translational Sciences Institute (CTSI) at:

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