FDA Policy/General

Animal Genomic Alteration Regulation Explained

FDA commissioner Scott Gottlieb and deputy commissioner for policy, legislation, and international affairs Anna Abram say the agency is implementing risk-based regulation of the safety and effectiveness of heritable intentional genomic alterations in animals. Writing in an FDA Voices blog post, the two say the innovations comprise changes made to an animal’s DNA, using technology such as genetic engineering and gene editing. The genetic changes can then be passed on to other generations of animals.

“Our new policy steps will help advance the ability to bring forward these innovative products in an efficient and predictable way,” Gottlieb and Abram write. “We’re also providing additional clarity about how our regulatory framework for intentional genomic alterations in animals works. We remain committed to safely and efficiently advancing these novel innovations.”

The post says FDA has already evaluated and approved several intentional genomic alterations in animals that produce drugs used to treat serious human diseases and illnesses. Another important use of animals with intentional genomic alterations that address human health is the production of better animal models to advance the study of new drugs that treat complex human diseases like cancer of heart disease, it says.

“The regulatory framework developed for intentional genomic alterations in animals is designed to be nimble in the face of rapidly advancing technology, while also providing clarity and predictability for researchers and developers on how the agency intends to regulate, or exercise discretion in enforcing, regulatory requirements, for intentional genomic alterations based on their inherent risks,” Gottlieb and Abram write. “Over the next year the agency expects to release additional information through guidance, to provide more clarity about this risk-based framework.”

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