Companies that produce generic drugs and APIs are required to self-identify to the FDA for FY2014 under the Generic Drug User Fee Amendments of 2012. The period extends from May 1 to June 1, 2013 and FDA uses the information to determine the cost for application reviews and inspections of companies. To read more on in-pharmatechnologist.com, click here. Need help with FDA registrations, contact us at 317.899.9341.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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