The FDA published a rule July 29 in the Federal Register announcing the re-establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research.
The committee advises the FDA Commissioner and designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use, the agency stated. In addition, 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 Commissioner.
The Medical Imaging Drugs Advisory Committee will be composed of a core of 12 voting members, including the chair. Members and the chair are selected by the FDA Commissioner or designee from among authorities knowledgeable in the fields of nuclear medicine, radiology, epidemiology or statistics and related specialties. Members will be invited to serve for overlapping terms of up to four years.
This rule is effective Aug. 5 and authority for the committee being established will end on May 18, 2013, unless the FDA Commissioner formally determines that renewal is in the public interest.