FDA to rule on MBI agent this month

Article

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.

Recent Videos
Improving Access to Nuclear Imaging: An Interview with SNMMI President Jean-Luc C. Urbain, MD, PhD
SNMMI: 18F-Piflufolastat PSMA PET/CT Offers High PPV for Local PCa Recurrence Regardless of PSA Level
SNMMI: NIH Researcher Discusses Potential of 18F-Fluciclovine for Multiple Myeloma Detection
SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease
Emerging Insights on the Use of FES PET for Women with Lobular Breast Cancer
Can Generative AI Reinvent Radiology Reporting?: An Interview with Samir Abboud, MD
Mammography Study Reveals Over Sixfold Higher Risk of Advanced Cancer Presentation with Symptom-Detected Cancers
Combining Advances in Computed Tomography Angiography with AI to Enhance Preventive Care
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
What New Research Reveals About the Impact of AI and DBT Screening: An Interview with Manisha Bahl, MD
Related Content
© 2025 MJH Life Sciences

All rights reserved.