FDA Signals Reporting Requirements for Clinical Trials Enforcement with First-ever Notice of Noncompliance to Drug Maker
By EsqSocial Corporation 30/04/21
On April 28, 2021, the US Food and Drug Administration (FDA) issued the first-ever Notice of Noncompliance after the drug maker did not comply with its legal reporting obligations for clinical trials upon earlier receipt of a Pre-Notice of Noncompliance from the agency. FDA notified the company that it has 30 days to correct the issue or face up to $10,000 per day in civil monetary penalties or other regulatory action including injunction or criminal prosecution....
By: Womble Bond Dickinson