In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.
To read the full text of this Duane Morris Alert, please visit the firm website.