About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

If the investigator’s explanation (either in writing or during an informal conference) is not accepted by FDA or if the investigator fails to respond to the NIDPOE within the specified time period, FDA will offer the investigator an opportunity for an informal regulatory hearing under 21 CFR part 16 (Part 16 hearing) to determine whether the investigator should remain eligible to receive certain investigational products. FDA initiates a Part 16 hearing by sending the investigator a Notice of Opportunity for Hearing (NOOH).

The NOOH specifies the facts and other relevant information that are the subject of the Part 16 hearing. If the investigator does not respond within the time period specified in the NOOH, FDA considers the offer for a hearing to have been waived, and no informal Part 16 hearing will be held. The Commissioner will consider the information in the administrative record to determine whether to disqualify the investigator.

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