Hello RAPS Community,
I have a couple of questions about submitting an annual report for IND. Here is some basic information.
1) review division: CDER 2) clinical trial has not started (no patient has enrolled) 3) No new non-clinical studies
1) We have not enrolled any patients and did not conduct any new non-clinical studies, and have no manufacturing or microbiological or labeling changes; I assume we do not need to submit the following documents.
Am I right?
2) We have updated stability data. We plan to (should we?) submit updated M 3.2.P.8.1, M 3.2.P.8.2, M 3.2.P.8.3, M 3.2.S.7.1, M 3.2.S.7.2, and M 3.2.S.7.3. Can we mention in the cover letter that we are submitting these updated documents? Or do we need to write something in the M 1.13.7 (Summary of Other Significant New information)?Thank you!
Individual study information
A brief summary of the status of each study in progress and each study completed during the previous year. The summary is expected to include the following information for each study:
The title of the study (with any appropriate study identifiers such as protocol number), its purpose, a brief statement identifying the patient population, and a statement as to whether the study is completed.
The total number of subjects initially planned for inclusion in the study; the number entered into the study to date, tabulated by age group, gender, and race; the number of participants who completed the study; and the number who dropped out of the study for any reason.
A brief description of any available study results.
Information obtained during the previous year's clinical and nonclinical investigations conducted under the IND application, including:
A narrative or tabular summary showing the most frequent and most serious adverse experiences by body system.
A summary of all IND safety reports submitted during the past year.
A list of subjects who died during participation in the investigation, with the cause of death for each subject.
A list of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug related.
A brief description of what, if anything, was obtained that is pertinent to an understanding of the drug's actions, including, for example, information about dose response, bioavailability, or relevant information from controlled trials.
A list of the preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major preclinical findings.
A summary of any significant manufacturing or microbiological changes made during the past year.
Update to Investigator's Brochure
Significant protocol updates
A description of any significant Phase 1 protocol modifications made during the previous year and not previously reported to the IND in a protocol amendment.
Update on foreign marketing developments
A brief summary of significant foreign marketing developments with the drug during the past year, such as approval of marketing in any country or withdrawal or suspension from marketing in any country.
A log of outstanding business
If desired by the sponsor, a log of any outstanding business with FDA with respect to the IND application for which the sponsor requests or expects a reply, comment, or meeting.
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