News & Analysis as of

Medical Research Reporting Requirements

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

BakerHostetler

Are You Complying with ClinicalTrials.gov Reporting Obligations?

BakerHostetler on

Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 4. In This Month's E-News: April 2020

Report on Research Compliance 17, no. 4 (April 2020) The Food and Drug Administration has accused a University of Michigan physician and professor of conducting research for more than three years after his approval from the...more

Holland & Knight LLP

CMS Issues Final Physician Payment Sunshine Rule

Holland & Knight LLP on

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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