FDA Re-Establishes Medical Drugs Advisory Committee

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The U.S. Food and Drug Administration (FDA) has published a rule that re-establishes its Medical Drugs Advisory Committee. The rule becomes effective today, with committee authority remaining in force until May 18, 2013 unless the FDA Commissioner formally determines that renewal is in the public interest.

Committee responsibilities encompass advising the FDA Commissioner and designee in discharging responsibilities as they relate to helping to ensure safe, effective drugs for human use, according to the agency. In addition, the committee reviews and evaluates data pertaining to the safety and effectiveness of marketed and investigational human drug products in diagnostic and therapeutic procedures that involve the utilization of radioactive pharmaceuticals and contrast media used in diagnostic radiology; and makes appropriate recommendations to the Commissioner.

The committee comprises 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.