111th Congress Archive
Federal Issues: 111th Congress – FDA Regulatory Policies, Process and Funding
HR 1346 (Pallone)—To amend the Federal Food, Drug, and Cosmetic Act with repsect to liability under state and local requirements respecting devices.
HR 1427 (Waxman)—To provide for licensing of biosimilar and biogenerics biological products.
HR 1548 (Eshoo)—To establish a pathway for the licensure of biosimilar biological products.
Letters, Testimony and Comments
CHI Statement to CDRH Town Hall, Irvine CA – Oct. 7, 2010 – October 8, 2010
CHI Submits Comments to FDA on 510(k) Reform Proposals – October 4, 2010
510(k)—Letter to FDA from Senators Boxer and Feinstein requesting extension of 510(k) comments period to ensure California stakeholder perspectives are considered—Sept. 10, 2010
Follow-On Biologics—CHI letter supporting Eshoo biosimilars amendment to House healthcare reform bill—July 17, 2009
Follow-on Biologics—CHI Statement for House Judiciary Biosimilars Hearing—July 14, 2009
Healthcare Reform Implementation Dates—April 19, 2009
Follow-on Biologics—CHI letter supporting introduction of HR 1548 (Eshoo) follow-on biologics legislation—March 17, 2009
Follow-on Biologics—CHI statement on introduction of HR 1427 (Waxman) follow-on biologics legislation—March 11, 2009