Letters, Testimony & Comments

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
May 16 2014
The member companies of BIO strongly support research that aims to improve human health through better drug development and recognize...
April 14 2014
GENERAL COMMENTS:   A. Comprehensive Approach to Pediatric Drug Development   BIO strongly supports a comprehensive...
September 13 2013
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
August 26 2013
Re: Docket No. FDA–2013–N–0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request...
August 5 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a...
July 10 2013
A concerted effort through the TTIP to unleash the potential of biotechnology in the Transatlantic economy and beyond will go a long way...
June 19 2013
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations...
June 19 2013
Countries across the globe are realizing the significant impact rare diseases have on their populations, and are responding by putting...
June 7 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the “WHO Guidelines on the Quality, Safety...
April 19 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
April 12 2013
Re: Docket No. FDA–2010-D-0643:  Draft Guidance for Industry on Electronic Source Data in Clinical Investigations;...
March 26 2013
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
March 18 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to...
March 4 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 27 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on...
February 4 2013
BIO respectfully submits both questions and comments for the National Health Surveillance Agency’s (ANVISA) consideration on the...
February 1 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
July 30 2012
Dear Sir/Madam: BIO thanks the FDA for the opportunity to provide comments on Modernizing the Regulation of Clinical Trials and...
May 31 2012
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA)...
May 21 2012
Good morning Chairman Rehberg, Ranking Member DeLauro, Members of the Committee, ladies, and gentlemen. I am Scott Koenig, President and...
March 20 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
January 17 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
November 28 2011
Given by Russell M. Medford, MD, PhD President and CEO, Salutria Pharmaceuticals, LLC BIO Board Standing Committee on Bioethics Co-...
November 16 2011
  Dear Dr. Menikoff:     The Biotechnology Industry Organization (BIO) thanks the Department of Health and Human...
October 26 2011
Dear Chairman Kingston and Ranking Member Farr: On behalf of the Biotechnology Industry Organization (BIO), I am writing to encourage...
May 12 2011
BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA April 28, 2011 The...
April 28 2011
The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine (IOM) for the opportunity to comment on the successes and...
April 28 2011
Hearing Testimony Scott Koenig, M.D., PH.D. Before the House of Representatives Committee on Small Business Good morning Chairman...
April 7 2011
On behalf of the Biotechnology Industry Organization (BIO) and its more than 1,100 member companies, academic institutions, state...
March 24 2011
Re: Docket No. FDA–2010–D–0616 Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational...
February 14 2011
Re: Docket No. FDA–2010–D–0529 Draft Guidance for Industry on Qualification Process for Drug Development Tools;...
January 24 2011
Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational...
December 28 2010
Re: Docket No. FDA-2010-D-0451: Draft Guidance for Industry on Suicidality: ProspectiveAssessment of Occurrence in Clinical Trials...
November 8 2010
BIO long has argued that actual and potential conflicts of interest in research should be identified, disclosed, and appropriately...
July 20 2010
Re: Docket No. NIH-2009-0002: Public Meeting on Expansion of the Clinical Trial Registry and Results Data Bank   Introduction...
June 22 2009
The Biotechnology Industry Organization (BIO) submits these comments on the European Medicines Agency’s (EMEA’s) draft...
May 23 2007
Docket No. 2004D-0440, Federal Register: October 4th, 2004 (Volume 69, Pages 59239-59240).
January 5 2005
Janna Tom, Assistant Director, Office of Technology Transfer, University of California; Vice President for Public Policy, Association of...
November 20 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
September 27 2004
September 8th, 2004 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,...
September 8 2004
In response to §1013 of the Medicare Prescription Drug, Improvement, and Modernization Act.
July 1 2004
The Honorable James Greenwood 2436 Rayburn House Office Building U.S. House of Representatives Washington, DC 20515 The Honorable...
September 17 2003
Good morning, Mr. Chairman and Members of the Committee. My name is Dr. Charles Johnson. I am Associate Director of Specialty...
April 23 2002
On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for $500 million for Cures...
May 20 2014
The importance of supporting biomedical research and innovation and the development of new therapies cannot be overstated. Today, we face increasing competition around the globe to overtake U.S. world leadership in biomedical innovation. Even in this time of budgetary constraint, it is crucial that we not allow this to happen. We cannot afford to lose the next generation of discoveries that address one of the nation’s leading cost drivers – chronic and debilitating disease.
May 16 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products; Notice of Public Hearing; Request for Comments.” BIO shares the Agency’s commitment to better engage populations traditionally under-represented in clinical studies, while maintaining a focus on speeding safe and effective medicines to patients in need.
April 14 2014
The member companies of BIO strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing their clinical trial data can help to advance such research, while reinforcing public trust in the clinical trial enterprise. 
September 13 2013
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 Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.” BIO commends FDA on the release of this Draft Guidance and shares the Agency’s commitment to ensure that safe and effective medicines are available for children.
August 26 2013
BIO fully supported the expansion and modernization of FDA’s Accelerated Approval pathway and the enactment of the new Breakthrough Therapy Designation Process under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA, P.L. 112-144).
April 7 2014
The EXPIRE Act would extend tax credits that expired at the end of 2013, including several of importance to the biotechnology industry.
November 18 2013
BIO commends the Senate for approving H.R. 3204, the Drug Quality and Security Act.
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.
March 28 2012
H.R. 4274 will encourage continued investment in pediatric research.
May 25 2011
BIO commends Reps. Davis (D-Ca) and Schwartz (D-PA) for their continued efforts to extend the Qualifying Therapeutic Discovery Project Tax Credit.