Drugs

Oncology Office Launches ‘Project Interface’

FDA’s Oncology Center of Excellence (OCE) has launched Project Interface, a new initiative aimed at deepening engagement with cancer patients, advocacy groups, and oncology professionals both in the U.S. and abroad. Under the theme “Making Cancer Personal at the FDA,” the initiative is designed to improve communication and collaboration around cancer awareness and treatment, with a focus on making scientific information more accessible to the public, according to an agency notice.

Through Project Interface, the agency will organize listening sessions and meetings with patient advocates and stakeholders, including discussions on critical topics such as pediatric cancer. The initiative will also support the White House Faith Office’s goal of empowering faith-based and community organizations to better serve families affected by cancer.

Key components of Project Interface include:

Facilitating panel discussions on a variety of cancer-related issues.
Publishing plain-language educational materials to enhance public understanding of cancer science.
Promoting international collaboration to address global cancer challenges.

Patient advocacy groups, faith-based organizations, and professional associations are encouraged to request meetings with OCE to share experiences, discuss collaboration opportunities, and explore strategies to reduce cancer incidence. For more information or to request a meeting, visit FDA’s Project Interface Web page or contact the team directly at OCE-Engagement@fda.hhs.gov.

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