IND/IDE Lifecycle Maintenance

For:

What is this service?

The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support for all submissions that may be required by an active IND or IDE, which might include:

·         Annual reports

·         Amendments

·         Safety and Adverse Event reports

·         Request for Withdrawal or Inactivation

·         All FDA forms and correspondence.

Who can use this service?

Any U-M investigator who is the sponsor-investigator for an IND/IDE can use this service.

When should I contact MICHR about this service?

You should contact MIAP as soon as an IND or IDE is granted or required.

How much does this service cost?

MIAP charges a flat fee of $75 per hour. Please contact MIAP for assistance with budgetary planning.

 

IND/IDE Lifecycle Maintenance

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Please provide us with information about your project.