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PET Drugs Without An IND Get Three More Years For Studies Under FDA Guidance

 
• By Brenda Sandburg

Q&A document from agency says sponsor does not have to use the same manufacturing process as the reference listed drug.

Producers of positron emission tomography (PET) drugs must be operating under an approved new drug application or abbreviated new drug application, or an effective investigational new drug application, by Dec. 12, 2015, FDA reminds manufacturers in its guidance on INDs for PET drugs.

The agency notes that it has not been enforcing the IND requirements pending completion of approval procedures and current good manufacturing practices for PET drugs, which were mandated under the 1997 FDA Modernization Act

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