Letters, Testimony & Comments

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Re: Docket No. FDA–2011-D-0530: Draft Guidance for Industry and Food and Drug Administration Staff on MobileMedical Applications Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food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RE: Comments Regarding the Draft Guidance on In Vitro Companion Diagnostic Devices; FDA-2011-D-0215 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit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...
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...
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...
September 30, 2011
  Re:  Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act; Interim Final Rules [CMS-9992-IFC2]   The Biotechnology Industry...
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...