Drugs

FDA Encouraging Clinical Trial Participation, Diversity

FDA says it is encouraging more patients to participate in clinical trials, especially people of different ages, races, ethnic groups, and genders. An agency Consumer Update says that overall, few people sign up for and participate in trials, and those who do participate don’t always represent the U.S. population. “Participation is especially low for certain populations,” it says, “including adults age 75 and older and people from certain racial and ethnic groups.”

To be sure that FDA has a full picture of a medical product’s risks and benefits, the report says, patients enrolled in a clinical trial should be representative of the types of patients who are likely to use the product if the agency approves or clears it.

“Certain populations can be more at risk for certain diseases, such as diabetes and heart disease, than others,” the agency says. “So it is important for patients in those populations who are more likely to be treated for a condition to be included in a trial.”

The Update discusses the reasons why few people participate in trials and describes the legal protections patients have and the risks and benefits of trial participation.

The agency is working with a variety of stakeholders, including federal partners, medical product manufacturers, medical professionals, and health advocates to encourage diversity, it says.

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