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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.
Emerging Perspectives on PSMA PET Radiotracers: An Interview with Kenneth J. Pienta, MD
April 24th 2024In a recent interview, Kenneth J. Pienta, M.D., discussed the impact of piflufolastat F18, current directions in research with other PSMA-targeted radiotracers and future possibilities for the role of PSMA PET in the imaging paradigm for prostate cancer.
