When do you need to submit an annual report for an Investigational New Drug (IND)?
IND application sponsors are expected to submit brief reports of the progress of the investigations conducted under their respective IND application within 60 days of the anniversary date that the application went into effect. Such reports are submitted annually and include information listed below. Form 1571 (PDF – 830KB) is expected to be sent along with each annual report submission.
Required documents and information
The information listed below is expected to be included in an IND Application Annual Report.
- IND Annual Report Cover Letter (Download Word Template)
- IND Annual Report Cover Page (Download Word Template)
- Form 1571 (PDF – 830KB)
- Table of Contents
- 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.
- Provide a statement confirming that the clinical trial oversight and monitoring, as outlined in the most recent version of the IND (referred to by IND# serial 0000) is being performed as described
- Summary information: 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 the General Investigational Plan: A description of the general investigational plan for the coming year to replace that submitted 1 year earlier.
- Update to Investigator’s Brochure: If the Investigator’s Brochure has been revised, a description of the revision and a copy of the new brochure. If there is no IB for this IND, or if no revisions were made to the IB during the reporting period, include a statement to that effect. If the IND is for an approved drug, indicate whether or not any changes were made to the approved package insert during the reporting period and include a copy of the updated package insert in the appendix.
- 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.