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You are here: Home / ALL NEWS / Analytical Testing News & Updates | ADPEN Laboratories / FDA Issues Final Guidance Regarding cGMPs for PET Drugs

FDA Issues Final Guidance Regarding cGMPs for PET Drugs

September 20, 2011 By Steven Perez

FDA issued a final guidance in early August regarding cGMPs for positron emission tomography (PET) drugs. The document covers resources, procedures, and documentation for PET drug-production facilities. The 1997 Food and Drug Administration Modernization Act called for these cGMPs to be established, and they are now part of 21 CFR Part 212. This guidance complements those requirements by providing information for small entities working on these drugs, such as academic and nonprofit facilities.

Read more about the FDA issuing final guidance regarding cGMPs for PET drugs on PharmTech.com.

Filed Under: Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links

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