Step 5: Preparing an FDA Regulatory Application or Exemption
In many cases, review by OCR or another Penn reviewing entity will be sufficient. However, in some cases, a submission to the FDA will be needed.
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DRUGS (includes biologics, food, dietary supplements)
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DEVICES
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IND Exemption Request Some exemption requests may need to be reviewed by the FDA. There are templates and submission instructions available. Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.
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IDE Exemption Request Some exemption requests may need to be reviewed by the FDA. There are templates and submission instructions available. Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.
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IND Application Pre-Submission Feedback There are mechanisms available to obtain feedback from the FDA prior to submission of an IND application (pre-IND meeting).
The FDA has a detailed guidance regarding the different types of meetings that may be requested, the request process, and timelines. Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu for additional guidance. |
IDE Application Pre-Submission Feedback There are mechanisms available to obtain feedback from the FDA prior to submission of an IDE application through the Q-submission process. The FDA has a detailed guidance regarding Pre-IDE Meeting requests, the request process, and timelines. Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu for additional guidance.
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IND Application On the OCR website, you can find the following templates and instructions:
The FDA also has an extensive website for Investigator Initiated Investigational New Drug (IND) Application.
FDA often has questions during the 30-day review period, and often there are short response deadlines. This should be taken into account prior to submission.
Please contact OCR Regulatory at psom-ind-ide@pobox.upenn.edu for additional guidance.
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Abbreviated IDE (aIDE) Application If you have a non-significant risk device, you will need to complete an aIDE application and submit it to the IRB. In certain cases, you may need to submit the aIDE application to the FDA.
Please reference the IRB website for additional details and contact OCR Regulatory at psom-ind-ide@pobox.upenn.edu for additional guidance.
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Full IDE (IDE) Application If you have a significant risk device, you will need to complete the full IDE application and submit it to the FDA. The FDA also has an informative website for preparing IDE Applications and has templates and instructions on the submission process. FDA often has questions during the 30-day review period, and often there are short response deadlines. This should be taken into account prior to submission. Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu for additional guidance.
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FDA Review Timelines IND exemption request – generally 30 days IND pre-submission – varies based on type of submission, refer to FDA guidance IND application – 30 days |
FDA Review Timelines IDE exemption request – 30-90 days, depending on submission mechanism IDE pre-submission – varies based on type of submission, refer to FDA guidance IDE application – generally 30 days
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