Drugs

PhRMA Strategies to Enhance Trial Diversity

Pharmaceutical Research and Manufacturers of America (PhRMA) and the Deloitte Center for Health Solutions have issued a report with five strategies for enhancing diversity in clinical trials during the research and development of new medicines. The report, “Enhancing Clinical Trial Diversity: Stakeholder Perspectives on Advancing Research Through Representative Clinical Trials,” is based on a year-long stakeholder engagement effort that included research and feedback from more than 500 stakeholders across over 150 organizations including community stakeholders, experts on clinical trials and in racial justice, patient advocates, healthcare practitioners, drug companies, academia, and more.

The strategies are:

create a network of clinical trial sites in underserved communities;
develop a diverse pool of investigators and staff;
establish long-term relationships and invest in the community;
engage the community in conversations; and
provide sustainable support and standardized platforms.

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