On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”). FDA’s stated purpose in issuing the guidance is to help sponsors to assure the safety of trial participants, maintain compliance with good clinical practice (“GCP”), and minimize risk to the integrity of trials during the ongoing Coronavirus Disease 2019 (“COVID-19”) pandemic.
The Guidance recognizes the impact COVID-19 may have on the conduct of ongoing clinical trials, including quarantines, site closures, travel limitations, interruptions to the supply chain, and other considerations should individuals involved in the studies become infected with COVID-19. FDA acknowledges that these factors may impact a sponsor’s ability to meet protocol-specified procedures, and that protocol modifications may be necessary and deviations unavoidable.
Blog Editors
Recent Updates
- New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device
- DOJ, HHS Announce Revamped False Claims Act Working Group
- HHS OIG Continues to Highlight How Medicaid Fraud Control Units Recovered $1.4 Billion in FY 2024
- OIG Says Medical Device Company's Proposal to Pay for Exclusion Screening for Customers May Violate the Anti-Kickback Statute
- DOJ Civil Division Announces 2025 Priorities: Promises “Aggressive” False Claims Act Enforcement of Civil Rights Violations and “Impermissible” Gender-Affirming Care