Following update was posted on What’s New section of ClinicalTrials.gov, on August 18, 2020:
- FDA Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020)
Information and links related to the FDA Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020) have been updated on the FDAAA 801 and the Final Rule, Support Materials, and Final Rule (42 CFR Part 11) Information pages. Additionally, an FAQ, To which trials do the potential legal consequences described in 42 CFR 11.66 apply?, has been updated.