FDA Re-Establishes Medical Drugs Advisory Committee

Julie Ritzer Ross | | Radiology Business | Business Intelligence
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.

Julie Ritzer Ross,

Contributor

Related Content

Orano Med breaks ground on $265M thorium production site
Image-interpretation market scoreboard: Radiologists 72%, others 28%
Lantheus lands rights to budding radiopharmaceuticals for initial outlay of $35M
17 short-term strategies to address the national radiologist shortage
‘SR’ onboards another independent practice, its 1st in the Natural State
Analysis: Allied radiology professionals generate millions of dollars per year in indirect revenues alone

Around the web

Health Imaging
Nearly $800,000 settlement offered to family of man who died during MRI exam

The patient, who was being cared for in the ICU, was not accompanied or monitored by nursing staff during his exam, despite being sedated.

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.