Letters, Testimony & Comments

June 19, 2012
We just heard our chairman Tom Watkins say "We're doing big things." Sounds good, but is that just hype, or is it for real? It's real. Together we do really big things. Today, I want to brag about some of the really big...
June 18, 2012
The Federal Circuit Court previously concluded that the claimed isolated genomic DNA and cDNA molecules in this case are patentable compositions of matter. Nothing in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (...
June 15, 2012
  The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Institute of Medicine’s (IOM’s) new report entitled,Ranking Vaccines: A Prioritization Framework, which was developed for the National...
June 15, 2012
  The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Institute of Medicine’s (IOM’s) new report entitled,Ranking Vaccines: A Prioritization Framework, which was developed for the National...
June 12, 2012
On behalf of the 23 undersigned industrial, environmental, food and agricultural biotechnology companies, we write to express our concerns over the pending appeal in the case of Association for Molecular Pathology et al. v. Myriad Genetics et al (...
May 31, 2012
Dear Sir/Madam: BIO thanks the FDA for the opportunity to provide comments on Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice. BIO strongly supports efforts by FDA, industry, academia, and patient groups to...
May 30, 2012
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our support for H.R. 5651, the Food and Drug Administration Reform Act of 2012, which includes a reauthorization...
May 21, 2012
Testimony of the Honorable James C. Greenwood President and CEO, Biotechnology Industry Organization Subcommittee on Conservation, Energy, and Forestry Committee on Agriculture U.S. House of Representatives May 18, 2012 The...
May 21, 2012
Comments of Biotechnology Industry Organization on EPA’s Science Advisory Board Deliberative Draft Report for Biogenic Carbon Accounting May 10, 2012  The Biotechnology Industry Organization (BIO) appreciates the opportunity to...
May 21, 2012
September 30, 2011 Det 1 AFRL/PKMD ATTN: Laura J. Ortiz 2310 Eighth Street, Bldg 167 Wright-Patterson AFB OH 45433-7801 Via email at: laura.ortiz@wpafb.af.mil Re: Comments of the Biotechnology Industry Organization in response to RFI-...
May 21, 2012
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry Drug Interaction Studies...
May 18, 2012
Re:      Proposed Project: Enrollment and Recertification of Entities in the 340B Drug Pricing Program (OMB No. 0915–0327)—Revision Dear Commander Pedley:         ...
May 17, 2012
  The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed rule specifying the Stage 2 criteria that eligible professionals (EPs), eligible...
May 16, 2012
BIO Public Statement Medicare Evidence Development & Coverage Advisory Committee Meeting Evidentiary Characteristics for Coverage with Evidence Development (CED)   Thank you for the opportunity to present comments on behalf of the...
May 14, 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Biosimilars User Fee Cover Sheet; Form 3792.”  BIO represents more than...
May 11, 2012
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval pathway for biosimilar and interchangeable biological products. The key issues she discussed included:...
May 11, 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the International Conference on Harmonisation proposed guideline on E2C(R2)...
May 10, 2012
    Dear Chairman Upton and Ranking Member Waxman: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our support for the Food and Drug Administration (FDA) user fee program legislation, which...
May 8, 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Drug Safety Information—FDA’s...