Home » Advocacy » Letters, Testimony & Comments

Letters, Testimony & Comments

Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)
February 1, 2010
Comments for HHS from BIO on Screening Framework Guidance for Synthetic Double-Stranded DNA Providers
January 26, 2010
Office of Medicine, Science, and Public Health Office of the Assistant Secretary for Preparedness and Response, FAO Jessica Tucker, Ph.D. U.S. Department of Health and Human Services 330 C Street, SW., Room 5008B, Washington, DC 20201...
Cap-and-Trade: BIO Asks California for Consistent, Accurate Accounting of Emissions Under Cap & Trade Rules
January 11, 2010
California’s cap-and-trade regulations should recognize that using biomass for biofuels is carbon neutral and does not contribute to global warming. We commented on the inclusion of indirect land use change estimates for biofuels under the...
BIO Amicus Brief, ACLU- Myriad
December 30, 2009
Format and Content of Proposed Risk Evaluation and Mitigation Strategies, REMS Assessments, and Proposed REMS Modifications
December 30, 2009
Draft Guidance, Clinical Considerations for Therapeutic Cancer Vaccines
December 17, 2009
Letter to Commissioner Seth Bradstreet, III, State of Maine Department of Agriculture, Food and Rural Resources commenting on the "Rule Requiring Use of Best Management Practices for Growing Crops to Minimize Cross Contamination"
December 14, 2009
Comments on the “Rule Requiring Use of Best Management Practices for Growing Crops to Minimize Cross Contamination” Dear Commissioner Bradstreet: On behalf of our members, the Biotechnology Industry Organization (BIO) respectfully...
BIO Comments on Recent USPTO International Work Sharing Initiatives
December 11, 2009
Cancer Vaccines: BIO Comments to FDA on Clinical Considerations for Therapeutic Cancer Vaccines
December 7, 2009
Comments asking for clarification on the method used to calculate a preclinical dose which exceeds the clinical dose, and recommends methods currently in practice for other non-oncology vaccines. We also propose incorporating a dosing schedule...
Sustainability Standards: Comments to Council on Sustainable Biomass Production
December 7, 2009
Comments recognizing the role of the Council’s draft sustainability standard in contributing to the growth of the biofuels industry.
FDA: BIO Comments to FDA on Providing Information to Consumers on Prescription Drug Risks and Benefits
November 25, 2009
We endorsed the development of a single written patient-oriented document to be used to communicate product benefit and risk information to patients. We believe that technology should be leveraged to enhance dissemination and distribution of the...
Providing Effective Information to Consumers about Prescription Drug Risks and Benefits
November 25, 2009
BIO Submits Comments on Revised Regulation 7CFR Part 340
November 24, 2009
BIO greatly appreciates the time and effort that has gone into the drafting of these proposed regulations. Although the agency has done an outstanding job of administering a challenging regulatory program that has enabled the safe development of...
BIO’s comments on the "The NCCN Comparative Therapeutic Index as a Paradigm for Near Term Comparative Effectiveness Analyses of Existing Data in Oncology"
November 23, 2009
Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on “Providing Effective Information to Consumers about Prescription Drug Risks and Benefits.” BIO believes...
Rare Disease Research: BIO Testifies on Accelerating Rare Disease Research and Orphan Product Development
November 23, 2009
We urged increased funding for the Orphan Drug Grant Program, the consideration of a longer U.S. exclusivity period, a more predictable regulatory approval pathway for orphan products, and additional guidance regarding orphan drug development. We...
Oral Statement to the Institute of Medicine Committee on Accelerating Rare Disease Research and Orphan Product Development
November 23, 2009
BIO/MBC testimony opposing Massachusetts House Bill 3012
November 19, 2009
Testimony of the Massachusetts Biotechnology Council (MBC) and the Biotechnology Industry Organization (BIO) Hearing of the Massachusetts Joint Committee on Natural Resources and Agriculture November 13, 2003 Regarding House Bills 3012: The...
Therapeutic Discovery Project: Support TDP During Healthcare Reform
November 19, 2009
As Congress considered healthcare reform patient advocacy groups submitted a letter to Congressional leadership asking for their support of the Therapeutic Discovery Project Tax Credit.
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
November 18, 2009
BIO’s comments on the "Report on the Evidence Regarding Off-Label Indications for Targeted Therapies used in Cancer Treatment"
November 16, 2009