Generic Biologics Legislation Unlikely, But Issue Not Going Away
Executive Summary
The push for legislation creating a follow-on biologics pathway is "cooling off," Senate Aging Committee majority counsel Steve Irizarry told the Stanford Washington Research Group conference in Washington, D.C. May 5
You may also be interested in...
Follow-Ons Off? FDA Shelves Near-Term Plans For Biologics Documents
FDA's decision not to release follow-on biologics documents in the near future suggests proponents of such products may turn their focus to Congress or the courts in an effort to establish a clear regulatory framework
Follow-Ons Off? FDA Shelves Near-Term Plans For Biologics Documents
FDA's decision not to release follow-on biologics documents in the near future suggests proponents of such products may turn their focus to Congress or the courts in an effort to establish a clear regulatory framework
USP Human Growth Hormone Monographs Issued; Generics Status Unresolved
U.S. Pharmacopeia's release of monographs on human growth hormone appears unlikely to significantly advance the debate over an abbreviated pathway for HGH follow-on products