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FDA to rule on MBI agent this month
The Food and Drug Administration has told ultrasound contrast developer Molecular Biosystems of San Diego that it expects to issue a final decision on ultrasound contrast regulation by July 28. The ruling should help clear up a regulatory morass that has
The Food and Drug Administration has told ultrasound contrast developer Molecular Biosystems of San Diego that it expects to issue a final decision on ultrasound contrast regulation by July 28. The ruling should help clear up a regulatory morass that has halted the review of most ultrasound contrast agents (SCAN 4/30/97).
The FDA in April suspended its regulatory review of MBI's Optison agent (formerly known as FS069) in response to citizen's petitions filed by competitors Bracco, Sonus Pharmaceuticals, and ImaRx Pharmaceutical and its partner Du Pont Merck. The FDA also froze its review of agents under development by those companies.
The petitioning companies charge that MBI has received preferential treatment from the FDA because Optison is being regulated by the agency's Center for Devices and Radiological Health, while their products are being reviewed by the Center for Drug Evaluation and Review.
In response to lawsuits filed by the three companies, the FDA was ordered by a U.S. District Court judge to review the merits of the citizen's petitions before proceeding with the review process. Late last month, MBI reported that the FDA has told the company that it expects to issue a final ruling on the matter by the end of this month.
European Society of Breast Imaging Issues Updated Breast Cancer Screening Recommendations
April 24th 2024One of the recommendations from the European Society of Breast Imaging (EUSOBI) is annual breast MRI exams starting at 25 years of age for women deemed to be at high risk for breast cancer.
Study Reveals Benefits of Photon-Counting CT for Assessing Acute Pulmonary Embolism
April 23rd 2024In comparison to energy-integrating detector CT for the workup of suspected acute pulmonary embolism, the use of photon-counting detector CT reduced radiation dosing by 48 percent, according to newly published research.
