Letters, Testimony & Comments

Tue, 2011-10-25 17:14
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...
Tue, 2011-10-25 17:08
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...
Tue, 2011-10-25 12:15
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...
Mon, 2011-10-24 17:16
  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...
Fri, 2011-10-21 11:54
  Biotechnology Industry Organization   Comments to the California Air Resources Board   On the Harmonization Chapter   October 21, 2011   The Biotechnology Industry Organization (BIO) appreciates the...
Fri, 2011-10-21 01:00
  Biotechnology Industry Organization   Comments to the California Air Resources Board   On the Harmonization Chapter   October 21, 2011   The Biotechnology Industry Organization (BIO) appreciates the...
Thu, 2011-10-20 17:18
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...
Thu, 2011-10-20 17:03
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...
Wed, 2011-10-19 17:20
Re: Docket No. FDA–2011-D-0530: Draft Guidance for Industry and Food and Drug Administration Staff on MobileMedical Applications Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food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 (...
Wed, 2011-10-19 01:00
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:...
Fri, 2011-10-14 01:00
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...
Tue, 2011-10-04 14:28
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...
Tue, 2011-10-04 01:00
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...
Fri, 2011-09-30 01:00
  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...
Mon, 2011-09-26 17:23
  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...
Mon, 2011-09-19 17:26
  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...
Tue, 2011-09-13 01:00
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,...
Mon, 2011-09-12 11:51
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...
Mon, 2011-09-12 01:00
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...