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Letters, Testimony & Comments

Potential NCD Topics: BIO's 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....
BIO Statement to the Presidential Commission for the Study of Bioethical Issues: Principles Regarding Ethical Performance of International Clinical Trials
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...
China Patent Enforcement Comments to USPTO
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:...
BIO's Prometheus v. Mayo Clinic Amicus Brief Filed
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...
Comments of Biotechnology Industry Organization on Economic Analysis to Implement the Clean Fuel Standard
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 (...
Comments of Biotechnology Industry Organization on Economic Analysis to Implement the Clean Fuel Standard
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 (...
International IP and Small Businesses: Novavax CEO Testifies on BIO's Behalf
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...
Human Subject Research Protections: BIO Comments on HHS ANPRM on Human Subjects Research Protections (Common Rule)
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...
EHB: BIO Public Statement: Essential Health Benefits Listening Session
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...
Sunshine: BIO co-signs letter to HHS Secretary Kathleen Sebelius
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...
Sunshine Letter to HHS Secretary Kathleen Sebelius
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...
PDUFA V: BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
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...
BIO Comments on the CARB on the Harmonization Chapter
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...
BIO Comments on the CARB on the Harmonization Chapter
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...
Paraguay IP Section 306 Monitoring: BIO Comments
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...
NADAC: BIO's Comments on the Survey of Retail Prices
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...
Mobile Medical Applications: BIO Comments
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 (...
Therasense USPTO Implementation: BIO Comments on the Revision of the Standard for the Duty to Disclose
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:...
Companion Diagnostics: BIO Comments on FDA Draft Guidance
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...
Comments of Biotechnology Industry Organization on Proposed Regulations to Implement the Low Carbon Fuel Standard
October 4, 2011
BEFORE THE CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD   Comments of Biotechnology Industry Organization on Proposed Regulations to Implement the Low Carbon Fuel Standard     BIO is the world...