Letters, Testimony & Comments

January 22, 2014
 Dear Commissioner Hamburg and Director Burwell: On behalf of the member companies of Biotechnology Industry Organization (BIO), we respectfully request that the Office of Management and Budget (OMB) issue the proposed Food and Drug...
January 21, 2014
Advancing Bioscience Industry Growth in Michigan: 2014 Best Practice Legislative Strategies To the Honorable Members of the 2014 Michigan Legislature: Thank you for providing BIO an opportunity to speak with you this morning and offer best...
January 3, 2014
 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: Permanent Discontinuance or Interruption in Manufacturing of...
December 19, 2013
On November 15, 2013, BIO submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding their Federally Qualified Health Center (FQHC) Prospective Payment System (PPS) proposed rule.    BIO’s comments...
December 18, 2013
December 16, 2013 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2013-N-1276: Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the...
December 12, 2013
U.S. HOUSE OF REPRESENTATIVES COMMITTEE ON OVERSIGHT & GOVERNMENT REFORM SUBCOMMITTEE ON ENERGY POLICY, HEALTH CARE & ENTITLEMENTS DECEMBER 12, 2013 “FDA CHECK-UP: DRUG DEVELOPMENT AND MANUFACTURING CHALLENGES” Chairman...
December 5, 2013
Thursday, December 5, 2013 U.S. Environmental Protection Agency’s Public Hearing for the 2014 Standards for the Renewable Fuel Standard Program, Docket Number: EPA-HQ-OAR-2013-0427 Hyatt Regency, Crystal City, 2799 Jefferson Davis...
November 27, 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 containing biotechnology-derived proteins as...
November 20, 2013
BIO commends the Brazilian Government for its efforts to revisit its policies with the goal of developing a legal framework that stimulates research and development based on Brazil’s rich genetic heritage. Given that technological advances...
November 18, 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Patient Counseling Information Section of Labeling...
November 6, 2013
November 6, 2013 The Honorable Robert Menendez 528 Hart Senate Office Building United States Senate Washington, D.C. 20510    The Honorable Patrick Toomey 248 Russell Senate Office Building United...
November 5, 2013
Re: Revision of USP Medicare Model Guidelines v6.0 for Benefit Years 2015-2017   Dear Members of the Therapeutic Information and Formulary Support Expert Committee:             The...
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...