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Letters, Testimony & Comments

Letter in Opposition of H.R. 2427, to House Speaker Dennis Hastert
July 15, 2003
The Honorable J. Dennis Hastert 235 Cannon House Office Building U.S. House of Representatives Washington DC 20510 Dear Speaker Hastert: On behalf of the 1,000 members of the Biotechnology Industry Organization (BIO), I would like to convey...
Phyllis Gardner Testimony
July 10, 2003
Chairman Bilirakis and Members of the Committee, I am pleased to testify before you today regarding technology transfer issues as they relate to the biotechnology industry. I would like to thank the Committee for its continued leadership on issues...
Letter to Mr. Gary Jackson, Asst. Administrator for Size Standards, U.S. Small Business Administration
July 7, 2003
Letter from 53 Senators Opposed to Importation
June 24, 2003
Dear Chairman Thomas, Tauzin and Grassley: As conference begins on reconciling the differences between the House and Senate versions of Medicare prescription drug legislation, we urge you to maintain the strong safety requirements pertaining to...
Comments regarding FDA's Guidance For Industry on Continuous Marketing Applications
June 17, 2003
Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No. 03D-0229, Federal Register: June 17, 2003 (Volume 68, Number 116, Page 35903) Dear Sir/Madam: The...
Statement of Michael J. Werner, Esq.
June 12, 2003
Statement of Michael J. Werner, Esq. Vice President, Bioethics Biotechnology Industry Organization Before the President's Council on Bioethics June 12, 2003 Good afternoon Mr. Chairman and members of this distinguished council. My name...
Premarketing Risk Assessments
May 29, 2003
Dear Sir/Madam: The following comments supplement those presented by the Biotechnology Industry Organization (BIO) at FDA's public meeting to discuss the Risk Management Concept Papers on April 9-11, 2003. BIO represents more than 1,000...
Risk Management
May 29, 2003
Dear Sir/Madam: The following comments supplement those presented by the Biotechnology Industry Organization (BIO) at FDA's public meeting to discuss the Risk Management Concept Papers on April 9-11, 2003. BIO represents more than 1,000...
Risk Assessment of Observational Data
May 29, 2003
Dear Sir/Madam: The following comments supplement those presented by the Biotechnology Industry Organization (BIO) at FDA's public meeting to discuss the Risk Management Concept Papers on April 9-11, 2003. BIO represents more than 1,000...
Letter to Sens. Judd Gregg and Edward Kennedy
May 19, 2003
Supporting legislation that prohibits genetic discrimination.
Letter to Hector Barreto
May 13, 2003
Administrator, U.S. Small Business Administration
BIO's comments regarding FDA's Guidance
May 7, 2003
BIO responds to the President's Council on Bioethics
April 15, 2003
Leon R. Kass, M.D., Chairman The President's Council on Bioethics 1801 Pennsylvania Avenue, NW Suite 800 Washington, DC 20005   Dear Dr. Kass: Thank you for your letter of March 14, 2003./1 In response, the Biotechnology...
Statement before the House Judiciary Subcommittee on the Courts, the Internet and Intellectual Property
April 3, 2003
Comments FDA's Draft Guidance For Collection of Race and Ethnicity Data in Clinical Trials
March 28, 2003
BIO Testimony on Project BioShield
March 27, 2003
J. Leighton Read, M.D. General Partner, Alloy Ventures Palo Alto, CA Testifying On Behalf Of The Biotechnology Industry Organization Before The House Energy And Commerce Subcommittee On Health And The House Select Committee On Homeland...
BIO letter opposing Weldon Bill and Supporting Greenwood/Deutsch Substitute
February 25, 2003
Letter to Mark McClellan regarding Personal Importation of Biological Products
February 14, 2003
The Honorable Mark B. McClellan Commissioner United States Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Re: Personal Importation of Biological Products Dear Dr. McClellan: The Biotechnology Industry...
Comments to the USTR
February 14, 2003
Identifying countries of concern as per the Trade Act of 1974
Letter, Concerns with Trade-Related Aspects of Intellectual Property (TRIPS)
January 29, 2003
Letter to The Honorable Robert Zoellick, US Trade Representative