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Letters, Testimony & Comments

Testimony on the Proposed Rule on Confidentiality of Patient Records
April 26, 2000
Testimony of Joanna C. Horobin, MD Executive Vice President For Commercial Development EntreMed Inc. on behalf of Biotechnology Industry Organization (BIO) Before the Senate Health, Education, Labor and Pensions Committee RE: The Proposed...
Testimony of Michael J. Werner, Esq.
March 10, 2000
Good afternoon. My name is Michael Werner. I am bioethics counsel for the Biotechnology Industry Organization (BIO). BIO represents more than 900 biotechnology companies, academic institutions, and state biotechnology centers engaged in...
Comments on Proposed Standards for Privacy of Individually Identifiable Health Information
February 15, 2000
Dear Dr. Hamburg: The Biotechnology Industry Organization ("BIO") is pleased to offer the following comments regarding proposed federal standards for protecting the privacy of individually identifiable health information maintained or...
Testimony of H. Stewart Parker
February 2, 2000
Good morning. I am Stewart Parker, CEO of Targeted Genetics Corporation, a biotechnology company based in Seattle, Washington. I am testifying on behalf of the Biotechnology Industry Organization (BIO), which represents 850 companies, academic...
Comments submitted to Secretary's Advisory Committee on Genetic Testing in response to the public consultation
January 31, 2000
Dear Dr. McCabe: The Biotechnology Industry Organization (BIO) represents 850 companies, academic institutions and state biotechnology centers engaged in biotechnology research on medicines, diagnostics, agriculture, pollution control and...
BIO's statement regarding reform of Hatch-Waxman Law
July 1, 1999
Executive Summary The Biotechnology Industry Organization (BIO) supports reforms of the Hatch Waxman Act that will provide full day-for-day restoration of lost patent term for drugs which require extended reviews and/or clinical trials for FDA...
Statement regarding confidentiality of patient medical records
May 27, 1999
The Biotechnology Industry Organization (BIO) is encouraged that the Subcommittee on Health and the Environment of the House Commerce Committee is holding this hearing and working to develop legislation to protect the confidentiality of patient...
BIO's testimony on patent reform to maximize innovation in the biotechnology industry
March 25, 1999
Executive Summary BIO supports amendments to the patent law that, above all, ensure that diligent patent applicants are not penalized for delays which are beyond their control. BIO has been working in support of amendments that will preserve the...
BIO Response to NBAC on Stem Cell Research
March 22, 1999
Harold Shapiro, Ph.D. Chairman c/o E. Randolph Hull National Bioethics Advisory Commission 6100 Executive Blvd., Suite 5B01 Rockville, MD 20892-7508 Dear Dr. Shapiro: Thank you for the opportunity to submit comments for NBAC's report...
BIO Statement Regarding Commercial Development of Pluripotent Stem Cells
January 12, 1999
EXECUTIVE SUMMARY Pluripotent stem cells research provides the hope of a new generation of therapeutics. Using cell transplants instead of drugs, biologics and other current therapies, provides new hope for patients with cancer, spinal cord...
Support of Voluntary Moratorium
March 27, 1997
March 27, 1997 The Honorable William J. Clinton President of the United States The White House Washington, D.C. 20500 Dear Mr. President: The recent cloning of a sheep from the genetic material of an adult cell has riveted the world....
Clinical Trials: Review of the Declaration of Helsinki
Re: Review of the Declaration of Helsinki   Dear Sir or Madam:   BIO appreciates the opportunity to comment on the World Medical Association’s (WMA’s) Declaration of Helsinki. The Biotechnology Industry Organization (...
Clinical Trials: ICTRP guidelines
Dear Dr. Sim: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50...
Questions for the District of Columbia Board of Pharmacy for the drafting of SafeRx
Questions for the District of Columbia Board of Pharmacy for the drafting of SafeRx Frequently Asked Questions Document • Is there a threshold, such as a percentage of time working in the District as a “detailer”, to require...
Letter to Governor Deval Patrick
RE: Concerns with Senate Bill 2863 Dear Governor Patrick, On behalf of the more than 1,200 members of the Biotechnology Industry Organization (BIO), I am writing to express concerns with SB 2863 "An Act to Control Cost Containment,...
BIO Testimony regarding Oregan Senate Bill 570
Testimony of the Biotechnology Industry Organization to the Oregon Senate Environment & Land Use Committee Regarding Senate Bill 570: The Oregon Genetically Engineered Pharmaceutical and Industrial Crop Act April 8, 2005 On behalf of the...
Letter to the Honorable John Carey
Dear Mr. Chairman: On behalf of the Biotechnology Industry Organization (BIO), I am writing to encourage you to consider the very significant promise that embryonic stem cell research offers thousands of Ohioans. There is a provision in House...
Sarbanes-Oxley in Financial Services Compromise: Sarbanes-Oxley 404(b) Legislative Text in the Wall Street Reform and Consumer Protection Act of 2009
BIO advocated for a provision in financial services reform that would ease regulatory burdens for small public biotechnology companies. The provision would permanently exempt companies with market capitalizations of $75 million or less from...
Sarbanes-Oxley in Financial Services Compromise : Joint Explanatory Statement of Sarbanes-Oxley 404(b) Provision
Sarbanes Oxley 404(b) recommendations made by the 2009 Government-Business Forum on Small Business Capital Formation
The 2009 Government-Business Forum on Small Business Capital Formation recommended a permanent exemption for small companies from Section 404(b) of Sarbanes-Oxley. Additionally, they recommended that the SEC increase the public float threshold for...