Bloomberg Law Quotes Shook Former FDA Attorney on COVID-19's Effect on Clinical Trials

Shook Of Counsel Sonali Gunawardhani was interviewed for “Clinical Trials May Hit Standstill to Focus on COVID-19,” by Bloomberg Law. The article focuses on FDA-issued guidance on managing health tech studies during a pandemic. Gunawardhana notes the health-care industry is preparing to postpone tests on novel medical products.

“Those running the studies have to not only be appropriately trained health-care professionals but also trained in clinical trial requirements, which is limited right now because all hands are on deck to help with COVID-19,” Gunawardhana said. She also mentioned, “You have people who are afraid to leave their house and aren’t even looking to enroll in a clinical trial.”

Gunawardhana offers clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges and is a former FDA attorney.