Accessibility disclaimer: To obtain information contained in document files on this page in an accessible format please contact the Human Subjects Office at (317) 274-8289. Or email the IU Institutional Review Board at firstname.lastname@example.org
Seeking Opinion from FDA Regarding Drug Exemption
Seeking FDA opinion on drug exemptions
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: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
Please use this address or call 301-796-3400 for drug products, including biological therapeutics.
For further information regarding drug and device development, please contact the Indiana Clinical Translational Sciences Institute (CTSI) at: email@example.com.