FDA ISSUES PROPOSED RULE ON CGMPS FOR PET DRUGS
The FDA has issued a proposed rule on current good manufacturing practices (cGMPs) for positron emission tomography (PET) drugs.
The proposed rule will establish minimum standards for the production and testing of PET drugs, the FDA said. The agency has also concurrently published a draft guidance, titled "PET Drug Products -- Current Good Manufacturing Practice." The guidance describes acceptable approaches for PET drug producers to meet the requirements of the proposed regulation.
PET is a medical diagnostic tool in which a radioactive drug is administered to a patient, most commonly by intravenous injection, and the distribution and uptake of the radioactive drug to various bodily organs is imaged using a scanner. The image helps physicians diagnose diseases such as cancer and heart disease.
The FDA Modernization Act of 1997 directed the FDA to establish new approval procedures and cGMP requirements for PET drugs, taking into account their special characteristics, the operations and processes required to produce these drugs, and any relevant differences between not-for-profit institutions that compound PET drugs for their patients, and commercial manufacturers.
To view the proposed rule, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/cd0279.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/cd0279.pdf). To view the draft guidance, go to, http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-0266-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-0266-gdl0002.pdf).