Nycomed receives warning from FDA
Contrast firm Nycomed Amersham of Princeton, NJ, received a warning letter from the Food and Drug Administration in September, according to the company. The warning came after a June inspection by the FDA of the firm's Arlington Heights, IL,
Contrast firm Nycomed Amersham of Princeton, NJ, received a warning letter from the Food and Drug Administration in September, according to the company. The warning came after a June inspection by the FDA of the firm's Arlington Heights, IL, radiopharmaceutical manufacturing facility. It cited Nycomed Amersham for neglecting to maintain FDA standards in the clean room in which NeoScan, indium DTPA, and thallous chloride are manufactured.
In addition, the letter raised concerns about Nycomed Amersham's ability to confirm the sterility of the agent technetium Tc 99m following reprocessing procedures, as well as the company's lack of standard protocols for cleaning and maintaining manufacturing equipment. The company is working closely to resolve the FDA's concerns, and there has not been any interruption of product deliveries, according to Carol Perlman, Nycomed spokesperson.
SNMMI: Can 18F-Fluciclovine PET/CT Bolster Detection of PCa Recurrence in the Prostate Bed?
June 24th 2025In an ongoing prospective study of patients with biochemical recurrence of PCa and an initial negative PSMA PET/CT, preliminary findings revealed positive 18F-fluciclovine PET/CT scans in over 54 percent of the cohort, according to a recent poster presentation at the SNMMI conference.
Could an Emerging PET Tracer be a Game Changer for Detecting Hepatocellular Carcinoma?
June 23rd 2025In addition to over 90 percent sensitivity in detecting hepatocellular carcinoma (HCC), the glypican-3 (GPC3) targeted PET tracer 68Ga-aGPC3-scFv appeared to be advantageous in identifying HCC tumors smaller than one centimeter, according to pilot study findings presented at the SNMMI conference.
SNMMI: What a New Meta-Analysis Reveals About Radiotracers for PET/CT Detection of PCa
June 22nd 2025While (68Ga)Ga-PSMA-11 offers a pooled sensitivity rate of 92 percent for prostate cancer, (18F)-based radiotracers may offer enhanced lesion detection as well as improved imaging flexibility, according to a meta-analysis presented at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) conference.
