Letters, Testimony & Comments

November 5, 2013
November 4, 2013  The Honorable Debbie Stabenow Chairwoman Senate Agriculture Committee 328A Russell Senate Office Building Washington, D.C. 20510     The Honorable Thad Cochran Ranking Member...
November 5, 2013
November 1, 2013  The Honorable Debbie Stabenow Chairwoman Senate Committee on Agriculture 328A Russell Senate Office Building Washington, DC 20510    The Honorable Thad Cochran Ranking Member...
November 5, 2013
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Specification of the Unique Facility Identifier...
November 4, 2013
November 4, 2013 The Honorable Debbie Stabenow U.S. Senate 328A Russell Senate Office Building Washington, DC 20510    The Honorable Thad Cochran U.S. Senate 113 Dirksen Senate Office Building...
October 31, 2013
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the revised “Guideline on Similar Biological Medicinal Products (CHMP/437/04 Rev1).” BIO commends EMA on...
October 29, 2013
On behalf of the more than 35 advanced biofuel companies listed below, we are writing to express our concern about a recently released draft of the proposed 2014 RFS volumetric blending requirement. While the official proposed rule has not been...
October 23, 2013
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine’s (IOM’s) Committee on Strategies for Responsible Data Sharing (the Committee) for the opportunity to submit written testimony...
October 16, 2013
BIO appreciates this fourth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin and we refer you to our previous comments filed to...
October 1, 2013
A collection of letters to Ambassador Kenneth M. Quinn, President of The World Food Prize Foundation from the agriculture value chain, universities and scientific experts applauding the support of biotechnology and its application to agriculture...
September 26, 2013
September 24, 2013 The Honorable Gina McCarthy Administrator U.S. Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, NW Washington, DC 20460 Dear Administrator McCarthy: On behalf of the members of the...
September 23, 2013
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 on Pre-Launch Activities Importation Requests.”...
September 17, 2013
Pennsylvania House of Representatives Health Committee Hearing House Bill 746 September 11, 2013 Good Morning: My name is Fritz Bittenbender and I am the Senior Vice President of External Affairs at the Biotechnology Industry Organization....
September 16, 2013
    September 6, 2013   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building...
September 16, 2013
September 6, 2013   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence...
September 16, 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments in response to its 2-day public meeting “Standardizing and Evaluating Risk Evaluation and...
September 13, 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the proposed rule “Administrative Detention of Drugs Intended for Human or Animal Use....
September 13, 2013
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 on Circumstances That Constitute Delaying, Denying,...
September 13, 2013
GENERAL COMMENTS:   A. Comprehensive Approach to Pediatric Drug Development   BIO strongly supports a comprehensive approach to pediatric drug development crafted in the best interests of children and greatly appreciates recent...
August 26, 2013
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 on Expedited Programs for Serious Conditions—...