Filing and Forms

Filing an IND/IDE application and preparation assistance

The FDA has set forth a specific format an IND application must follow. The IND Specialist will help in compiling an IND application and help the investigator assure that all the necessary documents are included.
 

The necessary documents needed to compile an IND include:

Forms:

Documents:

IND Submission Process:

Once the IND Application has been compiled as above, and submitted to the FDA Central Documents Office, the FDA will respond within 30 days with an acknowledgement letter and an IND number. This means that the IND has been successfully filed, however, the clinical investigation may not start until 30 days after the IND has been received by the FDA, unless earlier notification by FDA is received, stating, that the studies may begin.

After this acknowledgment, and within the 30 day window, the FDA may respond in one of three ways:

  1. The FDA may request additional information and may place clinical holds on your study or research. The study cannot begin until all concerns raised by the FDA have been addressed in ways acceptable to the FDA.
  2. The FDA may conclude that your project is exempt. An exemption means that the study or research may be conducted without filing an IND application.
  3. If there is no clinical hold placed on the study, and no further requirements are issued from the FDA after 30 days have elapsed, and the IRB approval is in place, the study may begin.

After approval of an IND, the Sponsor-Investigator is subject to the responsibilities set forth by the FDA for the sponsor/investigator of clinical trials.



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Contact Us: IND Specialist/Monitor 212-327-7408 or Kimberly.Bazylewicz@rockefeller.edu