For nuclear medicine professionals, December 11, 2011, is going to be a red letter day. This is when new regulations affecting the manufacture of PET imaging agents will go into effect.
During the recently concluded meeting of the Society of Nuclear Medicine (SNM)’s Clinical Trials Network, officials from the Food and Drug Administration (FDA) outlined how radiologists can help manufacturing sites comply with the agency’s Current Good Manufacturing Practice (CGMP) or 21 CFR Parts 210 and 211. For more information, see http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-0266-gdl0002.doc.
In a press release issued in conjunction with the workshop, Louis Marzella, MD, PhD, acting deputy director in the division of medical imaging and hematology products at the FDA, said “The FDA is enthusiastic about SNM’s efforts to work with the FDA and the drug development community to increasingly support the further development of safe and effective molecular imaging agents, drugs, and biologics.”
(Source: Press Release)
