Letters, Testimony & Comments

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...
October 21, 2011
  Biotechnology Industry Organization   Comments to the California Air Resources Board   On the Harmonization Chapter   October 21, 2011   The Biotechnology Industry Organization (BIO) appreciates the...
October 21, 2011
  Biotechnology Industry Organization   Comments to the California Air Resources Board   On the Harmonization Chapter   October 21, 2011   The Biotechnology Industry Organization (BIO) appreciates the...
October 20, 2011
By electronic submission   Mr. Stan McCoy Assistant USTR for Intellectual Property and Innovation Office of the U.S. Trade Representative Washington, D.C. Re:  Section 306 Monitoring of Paraguay: Memorandum of Understanding...
October 20, 2011
Dear Mr. Reed:             The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Survey of Retail Prices: Payment and Utilization Rates that will...
October 19, 2011
Re: Docket No. FDA–2011-D-0530: Draft Guidance for Industry and Food and Drug Administration Staff on MobileMedical Applications Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (...
October 19, 2011
The Honorable David Kappos Under Secretary of Commerce for Intellectual Property, Director of the U.S. Patent & Trademark Office Mail Stop Comments—Patents Commissioner for Patents P.O. Box 1450, Alexandria, VA 22313-1450 Att:...
October 14, 2011
RE: Comments Regarding the Draft Guidance on In Vitro Companion Diagnostic Devices; FDA-2011-D-0215 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug...