FDA Policy/General

FDA Pushing Clinical Trial Diversity

FDA assistant commissioner for minority health Jonca Bull says the agency is launching a campaign to encourage minorities to participate in clinical trials for all medical conditions. Writing in an FDA Voice blog post, Bull says the campaign will launch 6/19, World Sickle Cell Day, to “encourage diverse communities to learn more about how they can become a part of the research process to bring new therapies to the market.”

She writes that although the agency generally does not conduct clinical trials, it does the critical work in reviewing the data to assess the safety and efficacy of medical procedures before they can be used in medical practice. “None of this is possible without clinical trials and the patients who go the extra mile by being research participants,” she says. “In order to help ensure that medical products are safe for everyone, we need a diverse pool of research participants — racial and ethnic minorities, women, even the elderly.”

The campaign includes educational aids such as videos, a blog, and an infographic. Bull says the agency also is regularly working with stakeholder groups, supporting research, developing multi-lingual resources, and using social media to promote a community of “Clinical Trial Champions.”

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

Read more

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