Drugs

3 E&C Dems Urge FDA Issue Trial Diversity Guide

The three top Democrats on the House Energy and Commerce Committee are urging FDA commissioner Robert Califf to quickly issue a congressionally mandated guidance on clinical trial diversity action plans that was due on 12/29/2023. In their 2/20 letter, Reps. Frank Pallone (D-NJ), Anna Eshoo (D-CA), and Kathy Castor (D-FL) wrote, “Without FDA first publishing the draft guidance, sponsors will have difficulty preparing to carry out these diversity action plans. This draft is also the first step that must occur before the agency can enforce the Food and Drug Omnibus Reform Act of 2022 diversity action plan requirement, which goes into effect 180 days after the guidance is finalized. Thus, the failure to meet this critical deadline delays the implementation of important efforts to improve diversity in clinical trials.”

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