jueves, 12 de enero de 2017

FDA releases final guidance for "Nonproprietary Naming of Biological Products”

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
Today the Food and Drug Administration (FDA) released the final guidance for industry "Nonproprietary Naming of Biological Products."  The guidance describes our current thinking on the need for biological products previously and newly licensed under the Public Health Service Act (PHS Act) to bear nonproprietary names that include an FDA-designated suffix. Under this naming convention, FDA will designate a distinguishing suffix that is devoid of meaning and composed of four lowercase letters in the nonproprietary names for originator biological products, related biological products, and biosimilar products.  The suffix will be attached to each product’s core name with a hyphen. FDA is continuing to consider the appropriate suffix format for interchangeable products.
The FDA has carefully considered the appropriate naming convention to help ensure the safety of patients receiving biological products, enhance patient and prescriber confidence, and maximize the success of biosimilar and interchangeable biological products. 
The guidance is located at: Nonproprietary Naming of Biological Products

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