First company receives FDA violation notice for ClinicalTrials.gov submission omission
By EsqSocial Corporation 29/04/21
On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. In particular, FDA said Acceleron Pharma, Inc. violated the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act by failing…...
By: Hogan Lovells