Regulatory Focus™ > News Articles > User Fee Legislation for Generics and Biosimilars Released Ahead of Hearing

User Fee Legislation for Generics and Biosimilars Released Ahead of Hearing

Posted 09 February 2012 | By Alexander Gaffney, RAC 

Legislation establishing the user fee programs for generic drugs and biosimilar products was introduced in the House of Representatives on 9 February. The bill, To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars (H.R. 3988), now goes before the House Energy and Commerce Committee for markup.

The Committee is set to meet on 9 February to hear testimony from numerous government and industry officials, including Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for the Drug Evaluation and Research.



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