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Drug Information Update – Final Regulation on Positron Emission Tomography (PET) Drugs

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


Today, FDA published a final regulation and a related guidance document on positron emission tomography (PET) drugs. These drugs are given to patients to allow a special camera called a PET scanner to take images of internal organs and tissues. The images help physicians diagnose disease and assess specific health concerns.

Because PET drugs have a unique method of manufacture and unique conditions of use, FDA’s final regulations establish Current Good Manufacturing Practices (CGMP) specific to PET drugs. CGMPs are minimum standards that manufacturers should follow to ensure that drugs are safe and effective.

Unlike X-rays or magnetic resonance imaging (MRI) which show only body structure, PET images show the chemical functioning within an organ or tissue. This is useful in people with certain types of cancer or with other conditions. PET drugs contain a very small amount of radioactive material, and one of the distinctive properties is that the drugs must be given to patients within a few hours after being produced. Because these drugs are radioactive and have very short half-lives, they must generally be manufactured at or near the clinical sites where they will be given to patients.

FDA’s final regulation will help make sure that PET drugs meet requirements regarding safety, identity, strength, quality, and purity. The companion guidance document details FDA’s current thinking on CGMP for PET drugs and will guide PET producers in applying the final regulation.

For more information, please visit: PET


December 15, 2009 - Posted by | 1

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