User Fee Legislation for Generics and Biosimilars Released Ahead of Hearing
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.