Combo products: Which FDA regulatory pathway?

04/3/2007 | Pioneer Press (St. Paul, Minn.)

Device companies hoping to have a future are "going to have to figure out the merger between drugs, devices and biologics," particularly when developing combination products, according to an attorney who focuses on FDA issues. Carolyn Jones, the current vice president for technology and regulatory affairs at AdvaMed, noted that the FDA Web site offers examples and advice to help companies navigate the regulatory pathways and determine whether device or drug applications are needed.

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Pioneer Press (St. Paul, Minn.)

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