To kick off 2015, FDA has revealed a new database of guidance documents issued by the agency. An improvement on FDA’s prior organization system, the new database provides an up-to-date, user friendly, unified list of many guidance documents issued by all offices and centers within the agency. The system also provides multiple search functions that allow users to find documents by product type or FDA office. Further improvements to the database are to be expected, including additional information from FDA operation manuals, compliance guides, and alerts.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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