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
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
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
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
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
On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."
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Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more
On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results submission on the ClinicalTrials.gov...more