Drugs

Biotech Working Group Action Plan Coming

FDA commissioner Scott Gottlieb says that a Biotech Working Group named last month is preparing an action plan with steps the agency will take to ensure it has a flexible regulatory framework for evaluating the safety of products that also supports plant and animal biotechnology innovation. Gottlieb made the comment in an FDA Voice blog post co-written with agency deputy commissioner for policy, planning, legislation, and analysis Anna Abram.

According to the post, agency actions will focus on three key areas:

advancing and protecting public and animal health by promoting innovation through an efficient and predictable science- and risk-based regulatory framework;
strengthening public outreach and communication through strong, effective, and transparent engagement with stakeholders; and
increasing engagement with domestic and international partners through coordinated and collaborative actions to support regulatory alignment and efficiency.

Gottlieb and Abram say that products enabled by new techniques of biotechnology have the potential to significantly enhance public health. They describe several types of biotechnology innovation and commit FDA to taking “concrete and proactive steps to help ensure the safety of plant and animal biotechnology products, while promoting innovation and enhancing public and market confidence in FDA’s regulation of these products at home and abroad.”

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