Angela D. Ritter, M.D.
2 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
Subject (b)(6) continued to receive the investigational drug, (b)(4), between May 29, 2020, and March 28, 2022, instead of during the authorized two weeks only. This subject was administered an additional 50 doses of the investigational drug that were not authorized under IND #(b)(4) for individual patient expanded…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The subject received 50 additional doses of the investigational drug beyond the authorized two-week period, and no information or protocol amendments were submitted to FDA, failing to maintain an effective IND.
Supporting FDA text
Source excerpt · automated text-match checkSubject (b)(6) continued to receive the investigational drug, (b)(4), between May 29, 2020, and March 28, 2022, instead of during the authorized two weeks only. This subject was administered an additional 50 doses of the investigational drug that were not authorized under IND #(b)(4) for individual patient expanded access for emergency use. Additionally, you did not submit any information or protocol amendments to FDA regarding the change in the duration of the subject’s exposure to the investigational drug. As a result, you failed to maintain an effective IND for the expanded access use.
The clinical investigation was not conducted in accordance with the investigational plan because the subject received additional doses beyond the authorized two doses.
Supporting FDA text
Source excerpt · automated text-match checkSubject (b)(6) continued to receive the investigational drug, (b)(4), between May 29, 2020, and March 28, 2022. As a result, you failed to ensure that the clinical investigation was conducted in accordance with the general investigational plan and protocol contained in the IND.
The sponsor-investigator failed to obtain prospective IRB review and approval for subsequent use of the investigational drug and failed to ensure continuing IRB review.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to ensure that an IRB that complies with 21 CFR part 56 conducted prospective IRB review and approval for the subsequent use of the investigational drug following the authorized emergency access use. You also failed to ensure that an IRB that complies with 21 CFR part 56 continued to review and approve your continued conduct of the clinical investigation.
The sponsor-investigator failed to submit annual reports to FDA for the expanded access IND, despite being informed of the requirement.
Supporting FDA text
Source excerpt · automated text-match checkYou did not submit any annual reports for this IND, which you withdrew for completed treatment on April 27, 2023.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide information about any completed or proposed corrective actions that would prevent similar violations in the future, including policies and procedures to ensure that a clinical investigation is conducted according to the authorized protocol and to ensure that future studies will be conducted in compliance with applicable FDA regulations.
- Provide details on any planned or completed trainings on compliance with FDA regulations governing the conduct of clinical investigations, including the IND regulations at 21 CFR part 312.
- Provide sufficient details about a corrective action plan to ensure compliance with applicable FDA regulations, including any policies or procedures to ensure initial and continuing review and approval by an IRB that complies with 21 CFR part 56.
- Provide details about any completed or proposed trainings to ensure compliance with initial and continuing review and approval by an IRB that complies with 21 CFR part 56.
- Provide details about a corrective action plan to ensure compliance with applicable FDA regulations, including any policies or procedures to ensure that annual reports of the progress of the clinical investigation are submitted to FDA.
- Provide details on any completed or proposed trainings on compliance with FDA regulations governing the submission of annual reports for expanded access use.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.