Drugs

Draft Guide on Advanced Manufacturing Technologies

FDA has made available a draft guidance entitled “FDA Advanced Manufacturing Technologies Designation Program,” which is intended to outline a framework to enhance the reliability and robustness of pharmaceutical manufacturing processes. “Advanced manufacturing can integrate novel technological approaches, use established techniques in an innovative way, or apply production methods in a new domain where there are no defined best practices or experience,” the document says. These advancements have the potential to improve manufacturing and supply dependability, optimize development time, and ultimately benefit patients, it adds.

FDA encourages early adoption of AMTs [advanced manufacturing technologies] that demonstrate potential benefits in improving product quality and supporting a robust drug supply chain. The agency emphasizes the importance of AMTs in directly enhancing product quality through better manufacturing controls and reduced human interventions.

The draft guidance also provides recommendations to those interested in participating in the FDA's Advanced Manufacturing Technologies Designation Program. It outlines the eligibility criteria for AMT designation, the submission and assessment process for requests, and the benefits of receiving an AMT designation. Additionally, the guidance includes a question and answer section to address key concepts important for program utilization.

The agency says stakeholders are encouraged to familiarize themselves with the guidance document and engage with the FDA's Emerging Technology Team or Advanced Technologies Team before submitting AMT designation requests.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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

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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