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Enforcement Actions › Clinical Trials › Disclosure Requirements

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Arnall Golden Gregory LLP

Let’s Get Clinical: FDA Issues NOV Regarding Misleading Clinical Data Promotion

Arnall Golden Gregory LLP on

When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more

Morgan Lewis - As Prescribed

Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance

Morgan Lewis - As Prescribed on

The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

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