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# Don’t Approve Some Tc-99m NDAs: Petition
- URL: https://www.fdaweb.com/dont-approve-some-tc-99m-ndas-petition/
- Published: 2022-11-01T12:00:00.000Z
- Updated: 2026-09-14T18:04:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153095

A 10/28 citizen petition submitted by the Hyman, Phelps & McNamara law firm 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](https://downloads.regulations.gov/FDA-2022-P-2702-0001/attachment%5F1.pdf?ref=fdaweb.com) 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.”