Letters, Testimony & Comments

September 26, 2011
  Re: Docket No. FDA-2011-D-0239: Identifying the Center for Drug Evaluation and Research’s Science and Research Needs Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for...
September 19, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Amendments to Sterility Test Requirements for Biological Products.”  BIO supports...
September 13, 2011
Economic Development and Jobs for the Michigan Bioscience Industry Michigan House and Senate Standings Committee on the Biosciences Peter M. Pellerito, Interim Vice President Biotechnology Industry Organization, Washington, DC Tuesday,...
September 12, 2011
BEFORE THE CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD DRAFT CHAPTER ON ENVIRONMENTAL IMPACTS COMMENTS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION SEPTEMBER 12, 2011 The Biotechnology Industry Organization (BIO) is...
September 12, 2011
BEFORE THE CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD DRAFT CHAPTER ON ENVIRONMENTAL IMPACTS COMMENTS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION SEPTEMBER 12, 2011 The Biotechnology Industry Organization (BIO) is...
September 2, 2011
RE:      Comments on Proposed Definition of PCORI  1.   Does the definition place appropriate emphasis on, and convey the importance of, the “patient-centeredness” of the PCORI mission? Yes...
September 1, 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration’s (“FDA’s”) draft guidance document entitled Commercially Distributed In Vitro...
September 1, 2011
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “International Conference on Harmonisation (ICH); Draft Guidance on Q11 Development and Manufacture of...
August 15, 2011
Re: Docket No. FDA-2010-D-0530:  Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks...
August 9, 2011
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the core set of health quality measures for the Medicaid Quality Measurement Program created by the Affordable Care Act (ACA). BIO supports the development and...
August 5, 2011
BEFORE THE CALIFORNIAENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD     Comments of Biotechnology Industry Organization on     DRAFT LCFS Sustainability Principles, Criteria, Indicators Principles 4, 5, 6...
August 5, 2011
BEFORE THE CALIFORNIAENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD     Comments of Biotechnology Industry Organization on     DRAFT LCFS Sustainability Principles, Criteria, Indicators Principles 4, 5, 6...
August 2, 2011
Dear Senators Reid and McConnell and Representatives Boehner and Pelosi: We are deeply concerned about recent action in the U.S. House of Representatives to amend H.R. 2112, the Fiscal Year 2012 Agriculture, Rural Development, Food and Drug...
August 1, 2011
RE:     June 29, 2011 Memorandum on Proposed Changes to the Medicare Coverage Gap Discount Program – Low-Volume Claims and Clarifications The Biotechnology Industry Organization (BIO) appreciates this opportunity to...
July 29, 2011
  BIO fully supports the creation of an infectious disease standard by the Occupational Safety and Health Administration (OSHA) to protect healthcare workers (HCWs), and BIO believes that vaccinations should be an integral part of this...
July 28, 2011
The Biotechnology Industry Organization (BIO) is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,100 members worldwide. BIO members are involved in the...
July 25, 2011
The Honorable Michael J. Rogers 133 Cannon HOB U.S. House of Representatives Washington, DC 20515 Dear Representative Rogers: On behalf of the Biotechnology Industry Organization (BIO), I am writing with our support for H.R. 2405, the...