The U.S. Food and Drug Administration (FDA) has completed an inspection of contract development and manufacturing organization SpectronRx's South Bend, Indiana, manufacturing facility.
The inspection is part of a mutual recognition agreement between the FDA and the European Medicines Agency (EMA) and is a key step in the drug approval process for both regulatory agencies, SpectronRx said. Under the mutual recognition arrangement, the FDA and the EMA recognize each other's reviews of manufacturing sites, allowing companies to avoid duplicate inspections, according to the firm.
SpectronRx also announced that it is working to expand its U.S. Nuclear Regulatory Commission (NRC) materials license to include radium-226, which is key to developing the isotope actinium-225.
