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Letters, Testimony & Comments

BIO Testimony Against Importation
July 14, 2004
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE JUDICIARY COMMITTEE OF THE UNITED STATES SENATE IMPORTATION OF PRESCRIPTION DRUGS JULY 14, 2004 The Biotechnology Industry Organization (BIO) appreciates the opportunity...
Comments to CMS' proposed rule regarding the Hospital Inpatient Prospective Payment System and Fiscal Year 2005 Rates
July 12, 2004
Federal Register CMS-1428-P, May 18, 2004
Letter regarding "Patent Quality Improvement: Post-Grant Opposition"
July 8, 2004
BIO's final comments on FDA Draft Guidances on Risk Management
July 2, 2004
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.
BIO's final comments on FDA Draft Guidances on Risk Management
July 2, 2004
Development and Use of Risk Minimization Action Plans.
BIO's final comments on FDA Draft Guidances on Risk Management
July 2, 2004
Premarketing Risk Assessment.
Suggestions for research priorities to AHRQ
July 1, 2004
In response to §1013 of the Medicare Prescription Drug, Improvement, and Modernization Act.
"Patents Save Lives"
June 24, 2004
at the Global Public Policy Institute and Ecole de Science Politique
BIO CEO Letter Opposing Importation
June 7, 2004
Dear Majority Leader Frist: We, the undersigned biotechnology executives, strongly oppose further efforts to legalize prescription drug importation. Importation will put patients at risk, chill investment in biotechnology and other...
Comments to CMS' interim final rule regarding manufacturer submission of manufacturer's average saless price ("ASP") data for Medicare Part B drugs and Biologicals
June 7, 2004
Federal Register CMS-1380-IFC, April 6, 2004
BIO Comments
June 1, 2004
Re: Docket No. 2004N-0115 Request for Comment on Prescription Drug Importation Dear Dr. Carmona and Members of the HHS Task Force on Importation: The Biotechnology Industry Organization (BIO) submits the following comments in response to the...
BIO Letter to Louisiana Representative Sydnie Mae Durand
May 26, 2004
On behalf of the Biotechnology Industry Organization (BIO), please accept this letter in support of Senate Bill 74, a bill that would prohibit reproductive human cloning in Louisiana. We understand the Committee on Health & Welfare will...
BIO Letter to Louisiana Representative Sydnie Mae Durand
May 26, 2004
Supporting Senate Bill 74, which would preserve therapeutic cloning research in the state (May 26, 2004).
Letter on Project BioShield Passage
May 24, 2004
The Honorable Judd Gregg Chairman Committee on Health, Education, Labor and Pensions United States Senate Washington, DC 20510 The Honorable Edward Kennedy Ranking Member Committee on Health, Education, Labor and Pensions...
Letter opposing use of Bayh-Dole march-in powers
May 24, 2004
Before The Senate Committee On Health, Education, Labor, & Pensions
May 20, 2004
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE COMMITTEE ON HEALTH, EDUCATION, LABOR, & PENSIONS OF THE UNITED STATES SENATE IMPORTATION OF PRESCRIPTION DRUGS MAY 20, 2004 The Biotechnology Industry Organization (...
BIO Testimony
May 19, 2004
In opposition to New York Senate Bill 6537, which proposes to prohibit the sale of "transgenic aquatic animals" (May 19, 2004).
Comments regarding ICH E2E
May 19, 2004
Pharmacovigilance Planning (PvP).
Comments regarding ICH Q5E
May 19, 2004
Statement Before The NIH Blue Ribbon Panel
May 16, 2004
On Conflict of Interest Policies