Drugs

NIH Did Not Ensure Trial Reporting: OIG

An HHS Office of Inspector General (OIG) audit says the National Institutes of Health (NIH) failed to ensure that all clinical trial results were reported to ClinicalTrials.gov under federal requirements. The OIG audit found that most NIH-funded clinical trials that were completed in 2018 did not have their results posted.

“The noncompliance with federal reporting requirements occurred because NIH did not have adequate procedures for ensuring that responsible parties submitted the results of clinical trials, took limited enforcement action when there was noncompliance, and continued to fund new research of responsible parties that had not submitted the results of their completed clinical trials,” OIG says.

The OIG recommended that NIH: (1) improve its procedures to ensure that responsible parties of NIH-funded clinical trials comply with requirements to submit results to ClinicalTrials.gov on time; (2) take enforcement action against responsible parties that are late in submitting trial results or do not submit results; and (3) work with the responsible parties to understand their challenges related to ClinicalTrials.gov and implement procedures to address the challenges.

OIG says NIH agreed with the recommendations and described actions it has taken or plans to take to address them.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome