Letters, Testimony & Comments

February 25, 2011
Dear Majority Leader Reid and Minority Leader McConnell: On behalf of the Biotechnology Industry Organization (BIO), Advanced Biofuels Association (ABFA), Algal Biomass Organization (ABO) and our more than 100 advanced biofuels, renewable...
February 24, 2011
RE: Draft Update to Chapter 4 of the Medicare Managed Care Manual Dear Ms. Moon: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the Centers for Medicare & Medicaid Services (CMS) on the draft...
February 22, 2011
Re: Docket No. FDA–2010–N–0548: Good Laboratory Practice for Nonclinical Laboratory Studies Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
February 15, 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to participate in the Special 301 process and is hopeful that our contribution will assist the United States Trade Representative’s (USTR) efforts in preserving strong...
February 14, 2011
Re: Docket No. FDA–2010–D–0616 Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and...
February 1, 2011
No. 09-1159 IN THE Supreme Court of the United States ___________ BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY, Petitioner, v. ROCHE MOLECULAR SYSTEMS, INC., et al., Respondents. ___________ On Writ of Certiorari to the...
February 1, 2011
"An Act establishing procedures for sampling plants protected by patent or other intellectual property laws; requiring mediation of claims involving protected plants; providing an exception; providing rulemaking authority; and providing an...
January 24, 2011
Re: Docket No. FDA–2010–D–0529 Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
January 20, 2011
Compensation Tax Fund Will Hurt Farmers and Undermine Coexistence SUMMARY Coexistence in agriculture has been pushed to the forefront with policymakers, farmers and agriculture groups by the current “dialogue” in the context of an...
January 13, 2011
Re: Microsoft Corp. v. i4i L.P. and Infrastructures for Information Inc., pending in the United States Supreme Court, No. 10-290 Washington, D.C., December 22, 2010; With 90 additional signatories, January 13, 2011 Dear Attorney General...
January 11, 2011
Re: Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes [CMS-4144-P] Dear Dr. Berwick: The Biotechnology Industry Organization (BIO...
January 11, 2011
Re: Docket No. FDA-2010-D-0319 Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information; Availability Dear Sir/Madam: The Biotechnology...
January 11, 2011
Dear President Obama: The organizations below urge your Administration to maintain robust funding levels for the Department of Agriculture’s innovative clean energy programs in its upcoming Fiscal Year 2012 budget proposal. We recognize...
January 11, 2011
January 7, 2011 President's Council of Advisors on Science and Technology (PCAST) Public Oral Comments Ladies and Gentlemen: The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments today and would...
January 6, 2011
Farmers Successfully Practice Coexistence USDA must base its decision to deregulate GE alfalfa on science and within its existing statutory authority The U.S. Department of Agriculture is considering whether to deregulate genetically...
January 6, 2011
A report by Health Advances found that significant limitations in the current reimbursement system for novel diagnostics lead to inconsistent coverage decisions and impede the investment necessary for the development of the next generation of...
December 28, 2010
Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies Dear Sir/Madam: The Biotechnology Industry...
December 23, 2010
Dear Mr. Sunstein: The Biotechnology Industry Organization (BIO) wishes to express in the strongest possible terms its concerns regarding unilateral actions that the U.S. Department of Agriculture (USDA or the Department) is poised to take in...