Drugs

Petition Seeks Block on Some Tc-99m NDAs

A 1/20 citizen petition submitted by the law firm Hyman, Phelps & McNamara on behalf of Curium U.S. LLC asks FDA to refuse to approve any NDA seeking approval of a conventional Technetium-99m (Tc-99m) generator or Tc-99m product that relies on neutron capture technology given the advances in Tc-99m production that renders such an approach obsolete. The petition also requests that the agency refuse to approve any NDA for Tc-99m produced in generators implementing any new adsorbent technology other than alumina without first assessing potential impurities released by the new adsorbents and establishing impurity limits at levels shown to ensure patient safety of patients. Tc-99m is a radioactive pharmaceutical used in millions of medical diagnostic procedures each year.

The petition says that due to the limitations of conventional generators in producing safe and effective Tc-99m through neutron capture, including risks of breakthrough contamination and the potential for marketplace confusion that could result in medication errors, the benefits of such a Tc-99m product cannot outweigh the risks. “Given the eradication of these safety concerns by newer technologies, approving such a drug product would needlessly expose patients to safety risks without enhancing efficacy,” the petition says. “Consequently, FDA should refuse to approve a Tc-99m product produced through neutron capture in a conventional generator under section 505(d) of the Federal Food, Drug, and Cosmetic Act.”

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