Our US Food and Drug Administration (FDA) team recently published a blog post discussing the FDA’s issuance of its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health databank. While the authority to issue such notices has existed since the 2007 passage of the Food and Drug Administration Amendments Act, this is the first time the FDA has exercised its clinicaltrials.gov enforcement authority.
Legal Insights and Perspectives for the Healthcare Industry
We invite you to join our employee benefits and labor and employment teams for a webinar focused on the reopening issues and considerations to minimize difficulties as they begin to reopen or expand their operations.
In a recent LawFlash, our colleagues in the white collar practice discuss the potential for higher education institutions to face criminal and civil liability if they are not in compliance with federal law in the administration of federal grants and expenditure of federal research dollars, as recent cases tied to simultaneous research in China show.
We invite you to join our international trade and national security practice on Thursday, May 7, for a webinar on Foreign Influence and Conflicts of Interest in US Universities and Nonprofits Receiving Federal Funds.