Biologics

FDA, EPA, USDA Biotechnology Plan

As directed by a presidential Executive Order, FDA, EPA and the Department of Agriculture have developed a joint regulatory plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. An FDA statement (includes a link to the plan) says the plan “incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations.

The statement says the agencies have identified five major areas of biotechnology product regulations where their actions will focus: modified plants; modified animals; modified microorganisms; human drugs, biologics, and medical devices; and cross-cutting issues.

FDA says the three agencies intend to implement these joint efforts:

clarify and streamline regulatory oversight for generically engineered plants, animals, and microorganisms;
update and expand their information sharing through a memorandum of understanding to improve and broaden communication and coordination of oversight of modified microbes; and
undertake a pilot project focused on modified microbes to explore and consider the feasibility and costs of developing a Web-based tool that informs developers about which agency may regulate a given product category.

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