Drugs

FDA, NRC Ensure Domestic Technetium Supply

FDA says it and the Nuclear Regulatory Commission (NRC) have taken steps to ensure a stable and secure supply of Technetium-99m (Tc-99m), the most widely used radioisotope in medical imaging. An FDA news release says the agency approved NorthStar Medical Radioisotope’s RadioGenix System, a unique system for producing Tc-99m, while the NRC is issuing guidance and will license the RadioGenix System to enable the Tc-99m it produces to be used for its medical purpose.

The release says that while the radioisotope is vital to disease detection, healthcare professionals have faced challenges with adequate supply due to a complex supply chain that sometimes led to shortages.

“Today’s approval has been the result of years of coordination across FDA and with U.S. government organizations and marks the first domestic supply of Mo-99, the source of Tc-99m, in 30 years, which will help to ensure more reliable, clean and secure access to this important imaging agent used in nuclear medicine,” says CDER director Janet Woodcock.

Before this change, the release says, Molybdenum-99 (Mo-99), the parent of Tc-99m, could only be produced from enriched uranium by several facilities outside the U.S., requiring a complicated supply chain that involved shipping enriched uranium from the U.S. FDA says that process left the country vulnerable to possible shortages and/or supply chain issues.

The agency action granted approval for the RadioGenix System to produce sodium pertechnetate Tc-99m injection to ne injected intravenously, instilled into the bladder or eye, or used with other FDA-approved imaging drugs to examine specific tissues and organs. The approval did not require new clinical studies, the release says, because it relied on safety and efficacy information and data from an already approved TC-99m generator.

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