How Should the FDA Review Diagnostic Radiopharmaceuticals?

The purpose of this article is to reconsider the manner in which the U.S. Food and Drug Administration (FDA) reviews diagnostic radiopharmaceuticals.

Destroying the Linear No-threshold Basis for Radiation Regulation: A Commentary.

This article suggests five classes of effort that scientists can undertake to destroy the linear no-threshold hypothesis as the basis of radiation regulation in the United States. These are (1) pressure on regulators such as the Nuclear Regulatory Commission, (2) presidential messages, (3) Congressional pressure, (4) educate physicians about low-dose radiation, and (5) work with journalists and media people.

Time to Reject the Linear-No Threshold Hypothesis and Accept Thresholds and Hormesis: A Petition to the U.S. Nuclear Regulatory Commission.

On February 9, 2015, I submitted a petition to the U.S. Nuclear Regulatory Commission (NRC) to reject the linear-no threshold (LNT) hypothesis and ALARA as the bases for radiation safety regulation in the United States, using instead threshold and hormesis evidence.

Licensee over-reliance on conservatisms in NRC guidance regarding the release of patients treated with 131I.

Medical licensees are required to comply with U.S. Nuclear Regulatory Commission (NRC) regulations pertaining to the release of patients administered radioactive material.

A rational regulatory approach for positron emission tomography imaging probes: from "first in man" to NDA approval and reimbursement.

We propose a new regulatory approach for positron emission tomography (PET) molecular imaging probes, essential tools in today's medicine. Even though the focus of this paper is on positron-emitting labeled probes, it is also justified to extend this proposed regulatory approach to other diagnostic nuclear medicine radiopharmaceuticals. Key aspects of this proposal include: (1) PET molecular imaging probes would be placed in a "no significant risk" category, similar to that category for devices in current Food and Drug Administration (FDA) regulations, based on overwhelming scientific evidence that demonstrates their faultless safety profile; (2) the FDA-sanctioned Radioactive Drug Research Committee (RDRC) will oversee all diagnostic research with these probes.

Calculating the absorbed dose from radioactive patients: the line-source versus point-source model.

Unlabelled: In calculations of absorbed doses from radioactive patients, the activity distribution in such patients is generally assumed to be an unattenuated point source and the dose to exposed individuals at a given distance is therefore calculated using the inverse square law. In many nuclear medicine patients, the activity distribution is widely dispersed and does not simulate a point source. In these cases, a line-source model is proposed to more accurately reflect this extended activity distribution.

Lack of effect of a bisphosphonate (pamidronate disodium) infusion on subsequent skeletal uptake of Sm-153 EDTMP.

Patients who are candidates for samarium-153 ethylenediaminetetramethylenephosphonic acid (Sm-153 EDTMP) therapy often receive monthly infusions of pamidronate disodium or other bisphosphonates. Because both drugs are related compounds that concentrate in bone, it was advisable to determine whether previous bisphosphonate administration has blocked subsequent uptake of Sm-153 EDTMP. The authors compared skeletal uptake of Sm-153 EDTMP before and 1 to 4 days after pamidronate infusion in three patients with breast cancer metastatic to bone.

Administration guidelines for radioimmunotherapy of non-Hodgkin's lymphoma with (90)Y-labeled anti-CD20 monoclonal antibody.

90Y-ibritumomab tiuxetan is a novel radioimmunotherapeutic agent recently approved for the treatment of relapsed or refractory low-grade, follicular, or CD20+ transformed non-Hodgkin's lymphoma (NHL). (90)Y-ibritumomab tiuxetan consists of a murine monoclonal antibody covalently attached to a metal chelator, which stably chelates (111)In for imaging and (90)Y for therapy. Both health care workers and patients receiving this therapy need to become familiar with how it differs from conventional chemotherapy and what, if any, safety precautions are necessary.