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Noncompliance Clinical Trials

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 5. In This Month's E-News: May 2022

Report on Research Compliance 19, no. 5 (May, 2022) - Nearly a decade after irregularities were first noticed in clinical trials that ultimately led to a misconduct finding and a guilty plea for embezzlement, the HHS...more

Arnall Golden Gregory LLP

I Know There Was Something I Forgot to Do: FDA Issues Notice of Noncompliance for Failure to Submit Required ClinicalTrials.gov...

On April 27, 2021, the Food and Drug Administration issued its first Notice of Noncompliance to a pharmaceutical company for failure to submit required information to the ClinicalTrials.gov databank operated by the National...more

Mintz - Health Care Viewpoints

FDA Ups the Ante and Sends First Notice of Noncompliance for Failure to Submit Clinical Trial Results

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have the authority to regulate clinical trial reporting requirements. Despite this authority, FDA and NIH have scantly enforced this area...more

Womble Bond Dickinson

FDA Signals Reporting Requirements for Clinical Trials Enforcement with First-ever Notice of Noncompliance to Drug Maker

Womble Bond Dickinson on

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...more

Hogan Lovells

First company receives FDA violation notice for ClinicalTrials.gov submission omission

Hogan Lovells on

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...more

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