Month XX, 201X Food and Drug Administration Center for Drug Evaluation and Research Division of [Therapeutic Area] Central Document Room 5901-B Ammendale Rd. Beltsville, MD 20705-1266 OR Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center, HFM-99, Suite 200N 1401 Rockville Pike Rockville, MD 20852-1448 Re: IND Exemption Determination Request for proposed protocol entitled, Title of Protocol]” “[INSERT: Dear [INSERT: Reviewers‟ OR other appropriate salutation]: „FDA The purpose of this submission is to request a confirmation of my opinion that the above noted protocol meets the requirements for exemption from the Investigational New Drug regulations, 21 CFR 312. I believe the proposed research with meets the exemption requirements noted in 21 CRF [INSERT name of study drug] 312.2, specifically: 1. The investigational drug is lawfully marketed in the United States 2. The investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use of the drug product 3. The investigation is not intended to support a significant change in advertising to an existing lawfully marketed prescription drug product 4. The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product. 5. The investigation will be conducted in compliance with the requirements for institutional review set in FDA regulations 21 CFR 56, and requirements for informed consent as set forth in FDA regulations 21 CFR 50 6. The investigation will be conducted in compliance with FDA regulations 21 CFR 312.7: Promotion and charging for investigational drugs. Please see section for a description of [INSERT: Section number and name or cite page numbers in protocol] risk/benefit of this study. Thank you in advance for your attention and consideration of this request. Sincerely, [INSERT: Sponsor-Investigator name
Month XX, 201X Food and Drug Administration Center for Drug Evaluation and Research Division of [Therapeutic Area] Central Document Room 5901-B Ammendale Rd. Beltsville, MD 20705-1266 OR Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center, HFM-99, Suite 200N 1401 Rockville Pike Rockville, MD 20852-1448 Re: IND Exemption Determination Request for proposed protocol entitled, “[INSERT: Title of Protocol]” Dear [INSERT: „FDA Reviewers‟ OR other appropriate salutation]: The purpose of this submission is to request a confirmation of my opinion that the above noted protocol meets the requirements for exemption from the Investigational New Drug regulations, 21 CFR 312. I believe the proposed research with [INSERT name of study drug] meets the exemption requirements noted in 21 CRF 312.2, specifically: 1. The investigational drug is lawfully marketed in the United States 2. The investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use of the drug product 3. The investigation is not intended to support a significant change in advertising to an existing lawfully marketed prescription drug product 4. The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product. 5. The investigation will be conducted in compliance with the requirements for institutional review set in FDA regulations 21 CFR 56, and requirements for informed consent as set forth in FDA regulations 21 CFR 50 6. The investigation will be conducted in compliance with FDA regulations 21 CFR 312.7: Promotion and charging for investigational drugs. Please see section [INSERT: Section number and name or cite page numbers in protocol] for a description of risk/benefit of this study. Thank you in advance for your attention and consideration of this request. Sincerely, [INSERT: Sponsor-Investigator name
Template_IND_Cover%20Letter_Request_for_IND_Exemption.docx