Letters, Testimony & Comments

Fri, 2012-01-20 17:02
Re: Request for Comments Regarding Enhancements to the Part C and Part D Plan Ratings The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed...
Fri, 2012-01-20 00:00
Re:      CED Public Solicitation Dear Dr. Jacques:             The Biotechnology Industry Organization (BIO) is pleased to submit the following response to the Centers...
Tue, 2012-01-17 00:00
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Proposed Rule: Orphan Drug Regulations.”  As an...
Mon, 2012-01-09 00:00
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Retrospective Review under Executive Order...
Sat, 2011-12-31 00:00
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on “Concept paper on the revision of the guideline on similar biological medicinal products containing...
Fri, 2011-12-23 00:00
  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...
Fri, 2011-12-16 00:00
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...
Tue, 2011-12-13 00:00
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...
Fri, 2011-12-09 00:00
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...
Fri, 2011-12-02 00:00
  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...
Thu, 2011-12-01 02:00
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.  
Mon, 2011-11-28 00:00
  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...
Wed, 2011-11-23 02:00
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....
Wed, 2011-11-16 02:00
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...
Thu, 2011-11-10 11:58
By Electronic Submission Ip.policy@uspto.gov Office of Policy and External Affairs United States Patent and Trademark Office Alexandria, VA 22313-1450               Re:...
Mon, 2011-11-07 14:35
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...
Mon, 2011-10-31 14:33
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 (...
Mon, 2011-10-31 01:00
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 (...
Thu, 2011-10-27 01:00
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...