Biologics

FDA’s Gene Therapy Regulatory Role

A new National Academies book, Human Genome Editing: Science, Ethics, and Governance, says that FDA is one of several agencies and organizations that have a significant role in regulating both somatic and germline human genome editing. The publication says that human genome therapies are considered to be gene therapies with regard to FDA oversight, and the agency regulates human genome editing under the existing framework for biological products, which includes gene therapy products.

FDA has authorized some gene therapy trials, according to the book, but has not yet approved a gene therapy for market. If one is approved, it says, it will still be subject to FDA’s ongoing monitoring and, if necessary, restrictions on its use. “This FDA oversight entails review under rules governing biologics and, in many cases, under rules governing drugs,” it says.

Once gene therapies are introduced into clinical care, the book adds, not only will FDA maintain surveillance to detect safety concerns, but formal studies of the labeled uses also may be conducted to take a fresh look at the therapy’s safety and efficacy.

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