User Fee Legislation for Generics and Biosimilars Released Ahead of Hearing
Posted 09 February 2012 | By
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.