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February 8, 2016

Drug Naming Process Gets New Scrutiny From FDA


(Oli Scarff/Getty Images)

The Food and Drug Administration on Monday issued a notice seeking comments on the process of naming prescription drugs, particularly drug manufacturers’ desire to reserve a specific name for a drug product.

The naming process for a drug is normally associated with the regular approval process. The drug safety agency, which is keen on making sure the name of the product does not promote medication errors, earlier this year issued guidance on drug naming.

However, the FDA – spurred by negotiations with industry groups and Congress ahead of a 2007 FDA drug user fee reauthorization law – is considering the idea of reserving drug names ahead of the final approval of a drug.

Here’s a useful primer on how drugs are named from Dr. Suzanne Koven on

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