FDA cGMP requirements for PET drugs.

摘要

On December 9,2009, the U.S. Food and Drug Administration (FDA) issued a regulation (21 Code of Federal Regulations [CFR] Part 212) establishing Current Good Manufacturing Practices (cGMP) for PET drags. All PET drugs, such as ~(18)F-FDG, ~(18)F-NaF, and ~(13)N-ammonia, used in the clinical practice of nuclear medicine, regardless of whether they are obtained from a commercial vendor or an academic facility, must be manufactured in compliance with 21 CFR Part 212 by December 12, 2011. The rule requires the submission of a new drag application (NDA) or abbreviated new drug application (ANDA) for any PET drug product marketed for clinical use in the United States. In addition, all PET producers are also required to register with the FDA as a Drug Establishment by the December 12, 2011, deadline.