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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Investigational New Drug (IND) Application
  7. IND Application Reporting: Annual Reports
  1. Investigational New Drug (IND) Application

IND Application Reporting: Annual Reports

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.

The information listed below is expected to be included in an IND Application Annual Report.
 

 

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: 

  1. 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.

  2. 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.

  3. A brief description of any available study results. 

Summary information  

Information obtained during the previous year's clinical and nonclinical investigations conducted under the IND application, including: 

  1. A narrative or tabular summary showing the most frequent and most serious adverse experiences by body system.

  2. A summary of all IND safety reports submitted during the past year.

  3. A list of subjects who died during participation in the investigation, with the cause of death for each subject.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 

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. 


Note: FDA adopted the Guidance for Industry: E2F Development Safety Update Report (DSUR) (PDF - 272KB) which describes a common standard for periodic reporting on drugs under development among the ICH regions and is intended to meet the IND annual reporting requirements. To promote global harmonization, FDA will accept the DSUR to meet an IND application annual report requirements.

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