The below update has been posted on What’s New section of ClinicalTrials.gov PRS Test, which will go live on July 30, 2020:
- pACT Results Submission Change
As a result of a recent Federal court decision, some studies determined to be probable applicable clinical trials (pACT) under the FDA Amendments Act (FDAAA) that previously showed “[Not FDAAA required]” for Results Expected dates in the PRS now show “[30 days after approval]” instead. Results Expected dates are shown on the Record Summary page and in the Planning Report. For more information on this change, see the Frequently Asked Questions on the ClinicalTrials.gov public website.