Reston, Va.—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 will take 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. To access the recorded call, dial 800-756-0537. More information about the Clinical Trials Network and upcoming educational workshops is available at http://www.snm.org/clinicaltrials.
About SNM—Advancing Molecular Imaging and Therapy
SNM is an international scientific and medical organization dedicated to raising public awareness about what molecular imaging is and how it can help provide patients with the best health care possible. SNM members specialize in molecular imaging, a vital element of today's medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated.
SNM's more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit http://www.snm.org.