FDA Policy/General

Latest FDA Innovation Plan Announced

FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram say the agency is taking new steps to put in place modern regulations that foster innovation in plant and animal biotechnology through a new Plant and Animal Biotechnology Innovation Action Plan. “This new plan advances policy priorities that FDA will pursue to clarify our science-and-rule-based approach for product developers, avoid unnecessary barriers to future innovation in plant and animal biotechnology, and advance safety and our public health mission,” the two say in a statement.

The action plan identifies priorities in three areas: (1) advancing human and animal health by promoting product innovation and applying modern, efficient, and risk-based regulatory pathways; (2) strengthening public outreach and communication about FDA’s approach to innovative plant and animal biotechnology; and (3) increasing engagement with domestic and international partners on biotechnology issues.

As a first step, the two say, FDA will adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them. As part of the effort, FDA plans to publish two guidances over the next year to clarify how it is applying regulatory oversight to evaluate new animal biotechnology products based on the risk profile of various 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