The clinical trial results information submission deadlines for ACTs that fall within the scope of 42 CFR 11.42 are set out in 42 CFR 11.44. The standard submission deadline for results information is no later than 1 year after the study's primary completion date. (42 CFR 11.44(a)) However, an ACT with a primary completion date on or after January 18, 2017, would be eligible for delayed submission of results if the responsible party certifies that the ACT studies an FDA-regulated drug product (including a biological product) or device product that was not approved, licensed, or cleared by FDA for any use before the primary completion date, and that the sponsor intends to continue with product development and is either seeking, or may at a future date seek, FDA approval, licensure, or clearance of the product under study. (42 CFR 11.44(c)) Section 11.44(c) applies when a drug product (including a biological product) or device product being studied is not approved, licensed, or cleared by FDA for any use. The fact that the unapproved, unlicensed, or uncleared product is being studied in conjunction with or in comparison to an approved, licensed, or cleared product does not nullify the trial's eligibility for the delayed submission of results provision under 42 CFR 11.44(c). In addition, this fact does not require the products being used in conjunction with each other to be considered an approved, licensed, or cleared product, or to be a new use of a previously approved, licensed, or cleared product. As described in 42 CFR 11.42, an ACT of a drug, biological, or device product that is not approved, licensed, or cleared by the trial's primary completion date, and for which the primary completion date is before January 18, 2017, is not required to submit clinical trial results information.
For more information on the results information submission requirements, also see:
Am I required to submit results information for my applicable clinical trial (ACT)?
When is required clinical trial results information due?