vi. Annual reports 21 CFR 312.33

The sponsor-investigator must submit a progress report to the FDA within 60 days of the anniversary date that the IND went into effect.  The sponsor is also required under 21  CFR 312.33 to submit annual reports to the FDA on the progress of the clinical investigations.  (21 CFR 312.64).  The expected contents of the progress report are included in 21 CFR 312.33.