The U.S. Food and Drug Administration (FDA) is re-establishing the federal panel that advises the agency on drugs used to enhance medical imaging, and the FDA is seeking nominations to that committee.
On July 29, the FDA posted two Federal Register notices with the first entitled Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment and the second entitled Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs Advisory Committee.
The notice announcing the re-establishment of the medical imaging drugs advisory committee says, “the committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology and makes appropriate recommendations to the [FDA] commissioner.”
The “committee will be composed of a core of 12 voting members including the chair; members and the chair are selected by the commissioner or designee from among authorities knowledgeable in the fields of nuclear medicine, radiology, epidemiology or statistics, and related specialties,” the notice says. The regulation re-establishing the panel is effective August 5.
In addition, the notice seeking nominations for 12 members to serve on the committee in the Center for Drug Evaluation says the “final selection” for the vacancies will be determined by the expertise required to meet specific agency needs and in a manner to ensure appropriate balance on membership. Those selected will be invited to serve overlapping terms of up to 4 years. The deadline for nominations is Sept. 27.
Panel to Ensure Disabled Have Access to Medical Imaging Equipment
The proposed standards contain minimum technical criteria on medical diagnostic equipment and imaging equipment used by health care providers for diagnostic purposes