Biologics

4 Goals in CBER Strategic Plan

CBER has released its strategic plan for 2021-2025 containing four goals. CBER director Peter Marks says the plan is based on the Center’s mission and vision and outlines the goals, objectives, and strategies designed to further the mission and vision during the plan’s five-year term.

“Our plan aligns with HHS and FDA priorities and new authorities provided through the 21^st Century Cures Act,” Marks writes in the document’s introduction. “It reflects the contribution of all offices and divisions, and sets forth the Center’s four goals:

facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology;
conduct research to address challenges in the development and regulatory evaluation of medical products;
increase preparedness for emerging threats and promote global public health; and
manage for strategic excellence and organizational accountability.”

He says the plan reflects CBER’s priorities for the near term: address the Covid-19 outbreak; develop a regulatory program for individualized or bespoke therapies; facilitate compliance with human cells, tissues, and cellular and tissue-based product regulations, and advance manufacturing technologies for biologic products.

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