FDA Takes Further Steps To Set Clear Guidelines For PET Radiopharmaceuticals

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: MRI / PET / Ultrasound;  Heart Disease;  Cancer / Oncology
Article Date: 15 Dec 2009 - 3:00 PST

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The U.S. Food and Drug Administration (FDA) announced publication of a final regulation on current good manufacturing practices (cGMPs) for the production of positron emission tomography (PET) drugs, as well as a guidance document describing acceptable approaches that would enable PET drug producers to meet the requirements in the proposed regulation.

"We are pleased that FDA has issued cGMPs for PET drugs, which are so important to the diagnosis and treatment of patients with heart disease, cancer and other life-threatening illnesses," said Michael M. Graham, PhD, MD, president of SNM and director of nuclear medicine at the University of Iowa Carver College of Medicine.

The new FDA guidelines, which took effect December 11, 2011, are aimed at ensuring that PET drugs meet all requirements of safety, identity, strength, quality and purity. The cGMP guidance document describes acceptable approaches that would enable PET drug producers to meet regulatory requirements. All PET drug manufacturers will be required to submit a new drug application (NDA) or abbreviated new drug application (aNDA) for all PET drug products in routine clinical use by the date of implementation. In the interim, U.S. facilities must continue to comply with U.S. Phamacopeia <823>, which sets standards for the production of PET drugs.

SNM worked in concert with other medical organizations to provide FDA input and review on the cGMP guidelines. "This is a major step forward," said Graham. "Having a well-defined structure in place benefits manufacturers, physicians and patients by ensuring the highest quality drugs possible."

Through its Clinical Trials Network, SNM will offer educational programs on the new regulation. Representatives from FDA will discuss the new guidelines with the molecular imaging and manufacturing community at two upcoming events. FDA representatives will present a special session during the Clinical Trials Network Workshop, which will be held Feb. 1, 2010, at SNM's Conjoint Mid-Winter Meetings in Albuquerque, N.M. In addition, FDA representatives will present a half-day workshop at SNM's Annual Meeting, June 5, 2010, in Salt Lake City, Utah. To date, more than 130 manufacturing sites have registered with the Clinical Trials Network.

FDA's call announcing the new cGMP guidelines is available for replay through December 16. More information about the Clinical Trials Network and upcoming educational workshops is available at http://www.snm.org/clinicaltrials.

Source: Amy Shaw
Society of Nuclear Medicine

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