Letters, Testimony & Comments

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–020: Center for Drug Evaluation and Research Medical Policy Council; Request for Comments...
July 16 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 8 2013
Re: Docket No. FDA–2010-D-0643:  Draft Guidance for Industry on Electronic Source Data in Clinical Investigations;...
March 26 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on...
February 4 2013
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...
May 11 2012
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
March 29 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on...
February 29 2012
Given by Russell M. Medford, MD, PhD President and CEO, Salutria Pharmaceuticals, LLC BIO Board Standing Committee on Bioethics Co-...
November 16 2011
  Re: Docket No. FDA-2011-D-0239: Identifying the Center for Drug Evaluation and Research’s Science and Research Needs...
September 26 2011
Paul Hastings, testifying on behalf of BIO, discussed the importance of biotechnology in providing cures to diseases, and creating high-...
July 7 2011
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
Re: Docket No. FDA-2011-D-0057: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic...
April 18 2011
Re: Docket No. FDA-2009-N-0247-0260: FDA Transparency Initiative: Improving Transparency to Regulated Industry Dear Sir/Madam: The...
March 8 2011
Re: Docket No. FDA–2011–N–0002: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of...
March 2 2011
Re: Docket No. FDA–2010–N–0548: Good Laboratory Practice for Nonclinical Laboratory Studies Dear Sir/Madam: The...
February 22 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Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational...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
Re: Docket No. Docket No. FDA-2010-N-0506, Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic...
November 1 2010
Re: Docket No. FDA-2010-D-0246: Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems Dear Sir...
November 1 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes...
September 23 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug...
September 7 2010
On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment in support of the reauthorization of the...
April 12 2010
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
Re: Docket No. FDA-2009-D-0675, OC 20091. Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
April 13 2009
Re: Docket No. FDA-2008-D-0559, Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability...
January 21 2009
Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for the opportunity to testify before you today...
April 17 2007
The Biotechnology Industry Organization (BIO) welcomes this opportunity to comment on the success of the Prescription Drug User Fee Act (...
February 16 2007
November 14 2005
November 14 2005
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
October 18 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
September 27 2004
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.
July 2 2004
Development and Use of Risk Minimization Action Plans.
July 2 2004
Premarketing Risk Assessment.
July 2 2004
On Providing Regulatory Submissions in Electronic Format - General Considerations.
December 22 2003
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
November 17 2003
On Good Review Management Principles.
July 28 2003
Dear Sir/Madam: The following comments supplement those presented by the Biotechnology Industry Organization (BIO) at FDA's public...
May 29 2003
Dear Sir/Madam: The following comments supplement those presented by the Biotechnology Industry Organization (BIO) at FDA's public...
May 29 2003
Dear Sir/Madam: The following comments supplement those presented by the Biotechnology Industry Organization (BIO) at FDA's public...
May 29 2003
Letter from HHS Secretary Tommy Thompson
June 4 2002
Mr. Chairman and Members of the Subcommittee, I am Mary K. Pendergast, Executive Vice President for Government Affairs at Elan...
March 6 2002
Good morning. My name is Michael Werner. I am Vice President for Bioethics for the Biotechnology Industry Organization (BIO). BIO...
December 7 2001
September 16 2013
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 Mitigation Strategies.”  
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).
July 16 2013
 The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Center for Drug Evaluation and Research Medical Policy Council; Request for Comments.”
May 8 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format .”
March 26 2013
BIO thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance for Industry on Electronic Source Data in Clinical Investigations.”
August 6 2014
Survey responses will help inform Prescription Drug User Fee Act VI negotiations
January 9 2014
Nature Biotechnology published a peer-reviewed paper co-authored by the BIO Industry Analysis and BioMedTracker (BMT) highlighting results of a study showing that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2011 is near one in 10.
December 13 2013
BIO applauds the House of Representatives for passing a bipartisan budget deal, which raises discretionary budget caps, which should provide the Food and Drug Administration  with complete access to its user fees for FYs '14 and '15. 
December 12 2013
Hastings highlighted the need to advance the regulatory environment so that it fosters biopharma innovation. Among his recommendations, Hastings emphasized the need to eliminate the sequestration of industry user fees and expedite drug development for serious and life-threatening diseases by expanding the existing Accelerated Approval pathway and by facilitating the new Breakthrough Therapy Designation process.
July 29 2013
BIO released a statement in support of the FDA Safety Over Sequestration Act (H.R. 2725), which would exempt user fees, including those paid by BIO member companies, from the operation of sequestration.