NEMA - National Electrical Manufacturers Association
10/02/2024 | Press release | Distributed by Public on 10/02/2024 15:06
MITA Urges FDA to Maintain “One Stability, One Facility” Approach to PET Inspections
October 02, 2024
Arlington, Va. - The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), is urging the Food and Drug Administration (FDA) to maintain its "one stability, one facility" approach to inspections for positron emission tomography (PET) drugs (MITA Letter to FDA Regarding Policy Changes on Stability Sept. 13 2024).MITA, in conjunction with the Coalition of PET Drug Manufacturers, recently created a position paper on this topic.
PET drug products have annual stability testing performed at a single manufacturing facility because results are considered representative of batches produced at other facilities in the approved applications. The FDA's possible policy change regarding the "one stability, one facility" model does not seem to be linked to product safety concerns or product performance.
According to Sue Bunning, Managing Director of Positron Emission Tomography for the MITA PET Group, "This shift in regulating the manufacturing of PET drugs could unnecessarily limit patient access to radiopharmaceuticals which are essential to providing patients with an accurate diagnoses and access to a number of therapies. With positron emission tomography (PET), you cannot get the diagnosis without the drug."
The MITA PET Group is the leading organization and collective voice of radiopharmaceutical manufacturers, innovators, and product developers.###
About NEMA
The National Electrical Manufacturers Association (NEMA) represents over 300 electrical equipment and medical imaging manufacturers that make safe, reliable, and efficient products and systems. Together, our members contribute 1% of U.S. GDP and directly provide nearly 460,000 American jobs, contributing more than $250 billion to the U.S. economy. Learn more at www.nema.org
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Emily Druckman
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