The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to the Request for Information (RFI) Regarding Assessing Interoperability for MACRA (the “RFI”).1 BIO is the world's largest trade association representing biotechnology companies, academic…
Letters, Testimony & Comments | May 4, 2016 | BIO Announcements, Human Health
The Biotechnology Innovation Organization (BIO) would like to take the opportunity to follow-up and expand on the feedback we originally submitted to the Institute for Clinical and Economic Review (ICER) in October 2015 on the ICER Value Framework (the “Framework”).
Letters, Testimony & Comments | May 19, 2016 | Biotechnology Innovation Organization (BIO), BIO Statements, Food & Farm Innovation
The Biotechnology Innovation Organization (BIO) urges you and all members of the Senate Appropriations Committee to support a national bioengineered food labeling legislative solution, which Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI) are currently crafting in the Senate Agriculture…
Letters, Testimony & Comments | May 18, 2016 | Biotechnology Innovation Organization (BIO), BIO Announcements, BIO Leadership
The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the U.S. Food and Drug Administration (FDA) on the draft environmental assessment (EA)1 and preliminary finding of no significant impact (FONSI) regarding the proposed field trial of the OX513A…
Letters, Testimony & Comments | May 17, 2016 | Biotechnology Innovation Organization (BIO), Human Health
Dear Dr. Taichman:
The Biotechnology Innovation Organization (BIO) is pleased to offer the following comments on Sharing Clinical Trial Data: A proposal from the International Committee of Medical Journal Editors (“ICMJE”) (“the Proposal”). 1
BIO is the world's largest trade association…
The Biotechnology Innovation Organization (BIO) is pleased to submit these comments to FDA in response to FDA’s request for information on the use of the term “natural” on food labeling (docket no. FDA-2014-N-1207). BIO is the world's largest biotechnology trade association, representing companies,…
Letters, Testimony & Comments | May 9, 2016 | Human Health, Medicaid
The Biotechnology Innovation Organization appreciates this opportunity to submit comments on the Centers for Medicare and Medicaid Services’ proposed rule entitled Medicare Program; Part B Drug Payment Model...
Letters, Testimony & Comments | March 10, 2016 | Biotechnology Innovation Organization (BIO), Emerging Opportunities in Global Markets
The 2009 Government-Business Forum on Small Business Capital Formation recommended a permanent exemption for small companies from Section 404(b) of Sarbanes-Oxley. Additionally, they recommended that the SEC increase the public float threshold for being a small reporting company from having a…