FDA Policy/General

FDA EDDO Control Strategy Guidance Analyzed

A Journal of Regulatory Affairs article written by staff from FDA and several drug companies analyzes an agency 2024 draft guidance on essential drug delivery outputs (EDDO) for devices intended to deliver drug and biological products, focusing on risk-based control strategies, effective submission strategies, and when to engage with FDA. The article highlights regulatory expectations for EDDO upstream controls, discusses implementation challenges, and provides insights on practical approaches for robust submissions, including integrating prior knowledge, risk assessments, submission strategies, and global trends.

“The draft guidance provides a structured submission approach grounded in design control and International Council for Harmonization (ICH) principles,” it concludes, “guiding industry in developing and presenting robust control strategies to ultimately ensure patient safety…. Effective communication of holistic control strategies, including rationale and location within regulatory submissions, remains essential for health authority engagement. FDA encourages data-driven discussions and supports alignment on control strategies at key milestones, such as pre-BLA/NDA meetings, particularly for novel device designs or complex EDDOs. As the industry continues to adapt EDDO control strategy concepts, FDA is committed to clarifying expectations and ensuring alignment with ICH guidelines. Many of the considerations discussed are broadly applicable not only to EDDO but also to other device functional attributes, as the underlying principles remain consistent.”

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