Home » Advocacy » Letters, Testimony & Comments

Letters, Testimony & Comments

BIO Letter to Washington Representative Shay Schual-Berke, M.D.
January 31, 2005
Supporting House Bill 1268, which would preserve therapeutic cloning research in the state (January 31, 2005).
Comments on CMS's final rule with comment period regarding changes to the hospital outpatient prospective payment system (OPPS) and calendar year 2005 payment rates
January 14, 2005
Federal Register CMS-1427-FC, November 15, 2004
BIO and 21 Patient Groups Issue Letter Supporting FDA's Critical Path Initiative
January 12, 2005
Comments on Proposed Bulletin for Good Guidance Practices
January 9, 2005
BIO's comments on the Proposed Bulletin for Good Guidance Practices released by the Office of Management and Budget (OMB).
Comments on Outpatient Prospective Payment System
January 9, 2005
BIO's comments on the Centers for Medicare and Medicaid Servicesí final rule regarding revisions to the hospital outpatient prospective payment system (OPPS).
Comments on Draft Guidance on Computerized Systems in Clinical Trials
January 5, 2005
Docket No. 2004D-0440, Federal Register: October 4th, 2004 (Volume 69, Pages 59239-59240).
Comments on CMS's Revisions to Payment Policies Under Medicare Physician Fee Schedule
December 27, 2004
CMS-1429-FC.
Comments on CMS's Draft Formulary Review Criteria
December 23, 2004
As posted on CMS's Web site on December 3, 2004
Comments on CMS's Draft Decision Memorandum for Anticancer Chemotherapy for Colorectal Cancer
December 23, 2004
Scientific Considerations Related to Developing Follow-on Protein Products
December 13, 2004
Docket No. 2004N-0355.
Comments on FDA's Draft Guidance for Industry on a Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practices Regulations
December 3, 2004
Docket No. 2004D-0443, CDER 20041115.
The Role of Universities in Biotech Product Development and Capacity Building
November 20, 2004
Janna Tom, Assistant Director, Office of Technology Transfer, University of California; Vice President for Public Policy, Association of University Technology Managers (AUTM), USA Mission: -Research or Knowledge Generation -Education/Training...
Request for an extension of the comment period on the CMS draft coverage decision memorandum for anticancer chemotherapy for colorectal cancer
November 18, 2004
CMS Draft Decision Memo CAG-00179N, November 1 2004
UN Cloning Vote: BIO's letter to the Members of the U.N. General Assembly
November 16, 2004
To the Members of the U.N. General Assembly: The Biotechnology Industry Organization (BIO) represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and...
BIO's statement to IGC on genetic resources and patent disclosure requirements
November 5, 2004
Intervention of BIO Agenda Item 7 Patent Disclosure Requirements relating to Genetic Resources Thank you Mr. Chairman. The Biotechnology Industry Organization (BIO) commends the effort of the Committee to engage in a constructive...
Letter Expressing Appreciation for the Creation of the Independent Consultants Program.
October 28, 2004
Docket No. 03D-0112
BIO Comments on NAS Report
October 26, 2004
Reauthorization of the Prescription Drug User Fee Act
October 18, 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50...
Comments to the hospital outpatient prospective payment system (HOPPS)
October 8, 2004
Relating to CMS' proposed rule revisions from the Federal Register CMS-1427-P, August 16, 2004
Comments to CMS' proposed rule regarding revisions to the hospital outpatient prospective payment system (HOPPS)
October 8, 2004
Federal Register CMS-1427-P, August 16, 2004