Drugs

Group Petitions for More Trial Reporting Enforcement

Universities Allied for Essential Medicines (UAEM) North America is petitioning FDA for increased enforcement of the ClinicalTrials.gov reporting requirements under the FDA Amendments Act (FDAAA) of 2007. The petition, prepared and submitted by Columbia Law School’s Morningside Heights Legal Services, specifically asks that the agency:

increase enforcement of the clinical trial results reporting requirements in FDAAA;
publish a new guidance explaining how FDA will prioritize its enforcement efforts; and
create a public dashboard of preliminary notices of noncompliance sent to potentially noncompliant parties responsible for reporting clinical trial results.

In the petition, UAEM says it is an international nonprofit organization “committed to promoting health equity and access to medicines.” It says the petition is part of its ongoing initiative to increase data transparency in biomedical research. It cites its reports issued in 2019 and 2021 that found that despite some improvements in reporting rates over the past few years, noncompliance remains widespread.

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