1. Pink Sheet

FDA's Projected $20 Mil. In 2013 Biosimilar User Fees Translates Into 68 More Staffers

 
• By Cathy Dombrowski and Derrick Gingery

Administration’s proposed fiscal year 2013 spending plan includes $4.5 billion for FDA, with $2 billion or 44% provided by various user fees.

FDA expects that it will receive $20 million in user fees for biosimilar products in fiscal year 2013, enabling it to hire 68 employees for its biosimilars program.

Of the total, $11.8 million and 45.5 full-time equivalent staffing slots would be targeted for application reviews, including activities related to investigational new drug applications and inspections. Another $5.8 million and 22

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