Biologics

FDA Encouraging ‘Advanced Manufacturing’

FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah say the agency has sought to encourage and facilitate the adoption of “advanced manufacturing,” which they say refers to new and emerging approaches for producing medical technologies. Writing in an FDA Voices post, Hahn and Shah say that advanced manufacturing approaches apply to different medical product areas, including continuous manufacturing for drugs and 3D printing for patient-specific medical devices.

The post says that over the past decade, FDA has made strategic, forward-looking investments in personnel, policies, and processes to create a clear regulatory pathway for innovators across drug, biologics, and medical devices. They say FDA:

recognized that innovators seeking to adopt advanced manufacturing technologies may be concerned about the technical and regulatory challenges associated with transitioning away from their existing platforms;
recognized that policy must keep pace with innovation; and
supported research and partnerships that expand the knowledge base for advanced manufacturing.

The authors conclude that the Covid-19 pandemic “has shown how conventional manufacturing practices and predominantly international supply chains may be a liability for America’s emergency response efforts.”

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