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OIG audit finds lack of compliance with ClinicalTrials.gov reporting requirements from NIH studies

A newly released audit by the Office of Inspector General (OIG) found that for clinical trials funded by the National Institutes of Health (NIH) for which responsible parties were required to submit results to...more

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

HHS now requires public posting of a decade of clinical trial results that were previously exempted

Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data...

Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more

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