Letters, Testimony & Comments

December 23, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Center for Drug Evaluation and Research (CDER), Approach to Addressing Drug Shortage; Public...
December 16, 2011
Dear Sir/Madam: On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee program for biosimilar and interchangeable biological product applications (BsUFA).  BIO supports FDA...
December 13, 2011
These comments are submitted by the Biotechnology Industry Organization (BIO) in response to the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS or the Agency) Draft Environmental Impact...
December 9, 2011
By Electronic Submission To the State Intellectual Property Office, The Biotechnology Industry Organization (BIO) appreciates this opportunity to provide comments to the State Intellectual Property Office (SIPO) of the People’s Republic...
December 2, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Proposal for Public Comment to Increase Transparency By Promoting Greater...
December 1, 2011
On December 1, BIO submitted written testimony to the Senate Committee on Banking, Housing, and Urban Affairs on the importance of implementing policies that will spur job growth through capital formation while protecting investors.  
November 28, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...
November 23, 2011
Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) Medicare Coverage document entitled “Potential NCD Topics....
November 16, 2011
Given by Russell M. Medford, MD, PhD President and CEO, Salutria Pharmaceuticals, LLC BIO Board Standing Committee on Bioethics Co-Chair Madam Chairwoman and Members of the Commission: Good morning.  My name is Russell Medford, and I...
November 10, 2011
By Electronic Submission Ip.policy@uspto.gov Office of Policy and External Affairs United States Patent and Trademark Office Alexandria, VA 22313-1450               Re:...
November 7, 2011
In this case, the Supreme Court is being asked to decide whether diagnostic and personalized medicine claims that depend on a correlation of observed phenomena should be excluded from the patent system at the outset, as patent-ineligible abstract...
October 31, 2011
BEFORE THE CLEAN AIR ASSOCIATION OF THE NORTHEAST STATES   Comments of Biotechnology Industry Organization on Economic Analysis to Implement the Clean Fuel Standard     The Biotechnology Industry Organization (...
October 31, 2011
BEFORE THE CLEAN AIR ASSOCIATION OF THE NORTHEAST STATES   Comments of Biotechnology Industry Organization on Economic Analysis to Implement the Clean Fuel Standard     The Biotechnology Industry Organization (...
October 27, 2011
By electronic submission Saurabh Vishnubhakat Attorney Advisor, Office of Chief Economist United States Patent and Trademark Office Washington, D.C.   Name of Person Testifying: Stanley C. Erck, President and CEO, Novavax...
October 26, 2011
  Dear Dr. Menikoff:     The Biotechnology Industry Organization (BIO) thanks the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
October 25, 2011
Thank you for the opportunity to present comments on behalf of the innovative biotechnology industry which is working to prevent, treat, and cure diseases through the most advanced science. My comments today focus on the affordability and access...
October 25, 2011
October 25, 2011 Secretary Kathleen Sebelius U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Secretary Sebelius:  We are writing to urge you to fully implement Section 1128G of...
October 25, 2011
October 25, 2011 Secretary Kathleen Sebelius U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Secretary Sebelius:  We are writing to urge you to fully implement Section 1128G of...
October 24, 2011
  On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment on the reauthorization of the Prescription Drug User Fee Act (PDUFA).  BIO supports the PDUFA V recommendations as they will enhance the...