FDA Policy/General

NIH Streamlines Gene Therapy Oversight

The National Institutes of Health (NIH) has released its amended NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, that remove the requirement to register and report on human gene therapy protocols under the NIH Guidelines to the NIH. The amended guidelines stem from an 8/2018 joint FDA and NIH proposal to streamline duplicative and burdensome oversight over gene therapy. An NIH statement says that robust oversight continues under FDA, which has regulatory oversight of all human gene therapy clinical trials. Also, NIH-funded human gene therapy research remains subject to the usual NIH oversight that applies to all NIH-funded research, and oversight by local authorities such as institutional review boards and institutional biosafety committees.

Because of the changing landscape, the agency says, NIH is refocusing its recombinant DNA advisory committee into a role closer to its original mandate, which was to follow and provide advice on safety and ethical issues associated with emerging biotechnologies. The committee has been renamed the Novel and Exceptional Technology and Research Advisory Committee to reflect the boarder outlook, NIH says.

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