The FDA released a list of guidance documents that it is planning to publish in the 2013 calendar year. Guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers in 2013 is included in the list. To see the FDA list of future guidance, click here. To read more about the topic on in-pharmatechnologist, click here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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