Biologics

FDA Advanced Manufacturing Collaboration with NIST

FDA commissioner Stephen Hahn and senior advisor Colin Rom say the agency has signed a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products, and medical devices through the adoption of 21^st century manufacturing technologies. Writing in an online FDA Voices article, Hahn and Rom say they believe the FDA partnership with NIST will leverage the complementary skills of FDA’s regulatory expertise and NIST’s precision characterization and standards.

“The MOU establishes direct points of contact between senior leadership and collaborative links between subject matter experts to accelerate development and implementation of best practices for advanced manufacturing,” Hahn and Rom write. “These include many technologies that are poised to transform industry.”

The paper also describes three additional FDA initiatives to expand its commitment to advanced manufacturing:

CDER and CBER partnership to create a Center of Excellence for Advanced Manufacturing;
CDRH creation of an Advanced Manufacturing Technology Clearinghouse as an independent third party that identifies and evaluates promising advanced manufacturing technologies used in the medical device or other industries; and
CBER increased efforts to encourage the development and adoption of advanced manufacturing methods for critical vaccines.

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