FDA Submissions and Lifecycle Management

After an initial IND application is authorized by the FDA (also called receiving the “may proceed”) or an initial IDE application is approved by the FDA, the Sponsor is required to maintain a current application with the FDA. This section outlines ongoing and the final submission requirements. Refer to the WI Submitting to the FDA for details on how to submit. OCR Regulatory can assist you with templates, planners, and submission support. Please contact us at PSOM-IND-IDE@POBOX.upenn.edu.

IND Submissions to the FDA

Electronic submission is the preferred method for FDA IND submissions and a FDA form 1571 is always required (Form FDA 1571 and instructions).¹ Secure email communications with the FDA require use of PennMedicine email accounts.

They types of submissions required after the IND Application is authorized are summarized below² in the table, and more information can be found on the FDA Investigator-Initiated IND Applications webpage. Please contact OCR Regulatory for additional guidance via email at PSOM-IND-IDE@POBOX.upenn.edu.

IND Submissions^2,3	Submission Sub-types	Description of Submission	Submission and/or Implementation Requirement Timeline
Protocol Amendments	New Protocol	When a sponsor intends to conduct a study that is not covered by a protocol already contained in their IND application.	Submission must occur prior to implementation
	Changes to a Protocol	Any change in a Phase 1 protocol that significantly affects the safety of subjects; or Any change in a Phase 2 or 3 protocol that significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study.	Submission must occur prior to implementation
	Changes to a Protocol	Protocol change intended to eliminate an apparent immediate hazard to subjects	May be implemented immediately provided FDA is subsequently notified by protocol amendment
	New investigator	When a new investigator is added to carry out a previously submitted protocol	Notification to FDA within 30 days of the investigator being added
Information Amendments		Essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report.	Submitted as necessary but, to the extent feasible, not more than every 30 days
Safety Reports Must be submitted on a MedWatch Form FDA 3500A (Form and instructions)	15-day IND Safety Report	Potential serious risks, from clinical trials or any other source	No later than 15 calendar days after the sponsor determines that the information qualifies for reporting
	15-day IND Safety Report	SUSAR (Suspected Unexpected Serious Adverse Reaction)
	7-day IND Safety Report	Fatal or Life Threatening SUSAR	As soon as the information is available but no later than 15 calendar days after the sponsor receives the information.
	Follow Up IND Safety Report	Any relevant additional information that pertains to a previously submitted IND safety report.	As soon as the information is available but no later than 15 calendar days after the sponsor receives the information.
Annual Report		Updates on the preclinical, manufacturing and clinical (all studies under the IND) sections of the IND and to its investigational plan	Within 60 days of the anniversary date that the IND went into effect (the “May Proceed” date).
Withdrawal of an IND		Once all protocols under the IND are ended. If the withdrawal is for safety reasons, the notification must provide a report of the reasons.

1. 21 CFR §312.23.

2. NIH Clinical Center Regulatory Toolbox (IND Maintenance).

3. 21 CFR §312.30, §312.31, §312.32, §312.33, §312.38.

Electronic submission is the preferred method for FDA IND submissions and a FDA form 1571 is always required (Form FDA 1571 and instructions). Secure email communications with the FDA require use of PennMedicine email accounts. The types of submissions required after the IND Application is open are summarized below in the table and more information can be found on the FDA Investigator-Initiated IND Applications webpage.

2 IDE Submissions to the FDA

The types of IDE submissions required after the IDE application is approved are summarized in the table below1 and more information can be located on the FDA website IDE Reports and IDE Modifications.

There are three types of IDE maintenance submissions to the FDA: Amendments, Reports and Supplements.

3 Abbreviated IDE

Although original abbreviated IDE (aIDE) applications are not submitted to the FDA there are some instances where FDA reporting is required. The below table summarizes Abbreviated IDE reporting requirements to the IRB and FDA.

4 References

1. NIH Clinical Center Regulatory Toolbox.

2. FDA IDE Reports.

3. FDA Guidance for Industry: Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff, May 2001.

4. 21 CFR 812.150.