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Letters, Testimony & Comments

Jim Greenwood Address at 2006 BIO CEO & Investor Conference
February 14, 2006
This morning at breakfast I noted that this year's conference is our most well-attended yet. In just the past few hours, the numbers have continued to grow. We now have 1684 participants registered and still counting - even in the midst of a record-...
BIO Comments on Anti-Counterfeiting and Track-and-Trace Technologies
February 8, 2006
Letter to Representatives Judy Biggert and Anna Eshoo
February 7, 2006
Supporting the Genetic Information Nondiscrimination Act (GINA)
Fourth Meeting of the Ad Hoc Open-Ended Working Group on Access and Benefit-sharing, Granada, Spain
January 30, 2006
Comments on Exclusion of Vendor Purchases
January 20, 2006
BIO's Comments on the Centers for Medicare and Medicaid Servicesí interim final rule regarding exclusion of vendor purchases made under the Competitive Acquisition Program (CAP) for outpatient drugs and biologicals under Part B.
Comments on Reporting and Reviewing Adverse Events
January 13, 2006
Comments on the Revised Model Guidelines
January 6, 2006
To United States Pharmacopeia
Comments on Revisions to Payment Policies and the Competitive Acquisition Program
December 23, 2005
BIO's Comments on the Centers for Medicare and Medicaid Services' final rule regarding revisions to payment policies under the Medicare physician fee schedule and certain provisions related to the Competitive Acquisition Program.
Comments on Part B Local Coverage Determinations regarding drugs and their covered Diagnosis
December 14, 2005
BIOís comments on Noridian Admistrative Services draft LCD regarding drugs and their covered diagnosis.
Comments on Safe Harbor for Electronic Prescribing
December 13, 2005
BIO's comments on the Office of Inspector General's proposed Rule regarding new Safe Harbors for e-prescribing
Letter opposing amendments to the TRIPs agreement
December 6, 2005
BIO Comments to Draft Guidance on Gene Therapy Clinical Trials; Long-term follow-up
November 21, 2005
Statement by BIO at FDA Public Meeting
November 14, 2005
Summary of PDUFA Changes
November 14, 2005
BIO Comments on Draft Guidance on the Pediatric Research Equity Act
November 5, 2005
EMEAA's draft guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance
October 31, 2005
Comments on Systems of Records
October 28, 2005
Notices of new systems of records: "Data Collection Secondary to Coverage Decision System," "Anti-Cancer Chemotherapy for Colorectal Cancer System," and "Carotid Artery Stenting System"
BIO comments regarding manufacturer submission of average sales price data.
October 14, 2005
42 CFR 414.804 (CMS-10110)
Letter to Wisconsin Governor Jim Doyle
October 3, 2005
Dear Governor Doyle: On behalf of the Biotechnology Industry Organization (BIO) and the Wisconsin Biotechnology and Medical Device Association, I am writing to express concern with legislation that has been forwarded to you by the Wisconsin...
Clinical Trials: ICTRP guidelines
September 30, 2005
BIO urges the ICTRP to focus on developing a procedure that would address the need to balance the incentive to innovate with the need to provide patients and health care providers with the information they need in order to assess the availability...