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Letters, Testimony & Comments

SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
February 4 2013
FDA Public Meeting: Approval Pathway for Biosimilar and Interchangeable Biological Products
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...
May 11 2012
BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
March 29 2012
Good Guidance Practices: FDA Report on Good Guidance Practices: Improving Efficiency and Transparency
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on...
February 29 2012
BIO Statement to the Presidential Commission for the Study of Bioethical Issues: Principles Regarding Ethical Performance of International Clinical Trials
November 16, 2011
Given by Russell M. Medford, MD, PhD President and CEO, Salutria Pharmaceuticals, LLC BIO Board Standing Committee on Bioethics Co-...
November 16 2011
CDER Science & Research Needs: BIO Comments on CDER Draft Report
  Re: Docket No. FDA-2011-D-0239: Identifying the Center for Drug Evaluation and Research’s Science and Research Needs...
September 26 2011
Testimony before House Energy and Commerce Subcommittee on Health
July 7, 2011
Paul Hastings, testifying on behalf of BIO, discussed the importance of biotechnology in providing cures to diseases, and creating high-...
July 7 2011
BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA)
June 9, 2011
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
FDA's Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets
April 18, 2011
Re: Docket No. FDA-2011-D-0057: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic...
April 18 2011
BIO Comments on FDA Transparency Initiative: Improving Transparency to Regulated Industry
March 8, 2011
Re: Docket No. FDA-2009-N-0247-0260: FDA Transparency Initiative: Improving Transparency to Regulated Industry Dear Sir/Madam: The...
March 8 2011
BIO Testifies at FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
March 2, 2011
Re: Docket No. FDA–2011–N–0002: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of...
March 2 2011
BIO Submits Comments on FDA’s Good Laboratory Practice for Nonclinical Laboratory Studies
February 22, 2011
Re: Docket No. FDA–2010–N–0548: Good Laboratory Practice for Nonclinical Laboratory Studies Dear Sir/Madam: The...
February 22 2011
BIO Comments on Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies
December 28, 2010
Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational...
December 28 2010
Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials
November 8, 2010
Re: Docket No. FDA-2010-D-0451: Draft Guidance for Industry on Suicidality: ProspectiveAssessment of Occurrence in Clinical Trials...
November 8 2010
FDA: Strategic Priorities for Fiscal Year 2011-2015
November 1, 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
FDA Guidance Document: Transdermal Drug Delivery Systems
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
FDA: Chemistry, Manufacturing, and Controls (CMC) Reporting
September 23, 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes...
September 23 2010
FDA: Investigational New Drug Applications; Co-Development of Investigational New Drugs
September 7, 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug...
September 7 2010
Reauthorization of the Prescription Drug User Fee Act (PDUFA)
April 12, 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
Food and Drug Administration Transparency Task Force, Public Meeting
November 6, 2009
November 6 2009
BIO Testifies on Importance of Data Exclusivity and Patent Protection in Pathway for Approval of Biosimilars
July 15, 2009
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
The Draft Guidance for Industry on Good Importer Practices
April 13, 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
FDA Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability
January 21, 2009
Re: Docket No. FDA-2008-D-0559, Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability...
January 21 2009
Testimony before the House Committee on Energy and Commerce, Health Subcommittee
April 17, 2007
Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for the opportunity to testify before you today...
April 17 2007
Statement by BIO at FDA Public Meeting
February 16, 2007
The Biotechnology Industry Organization (BIO) welcomes this opportunity to comment on the success of the Prescription Drug User Fee Act (...
February 16 2007
Statement by BIO at FDA Public Meeting
November 14, 2005
November 14 2005
Summary of PDUFA Changes
November 14, 2005
November 14 2005
Letter Expressing Appreciation for the Creation of the Independent Consultants Program.
October 28, 2004
Docket No. 03D-0112
October 28 2004
Reauthorization of the Prescription Drug User Fee Act
October 18, 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
October 18 2004
BIO's Comments to FDA's Proposed Rule on Institutional Review Board (IRB) Registration Requirements
September 27, 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
September 27 2004
BIO's final comments on FDA Draft Guidances on Risk Management
July 2, 2004
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.
July 2 2004
BIO's final comments on FDA Draft Guidances on Risk Management
July 2, 2004
Development and Use of Risk Minimization Action Plans.
July 2 2004
BIO's final comments on FDA Draft Guidances on Risk Management
July 2, 2004
Premarketing Risk Assessment.
July 2 2004
BIO Comments on FDA's draft Guidance for Reviewers
December 22, 2003
On Providing Regulatory Submissions in Electronic Format - General Considerations.
December 22 2003
BIO Comments on FDA's Statement of Work for the Evaluation of First Cycle Review Performance
November 17, 2003
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
November 17 2003
BIO's Comments regarding FDA's draft guidance
July 28, 2003
On Good Review Management Principles.
July 28 2003
Premarketing Risk Assessments
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
Risk Management
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
Risk Assessment of Observational Data
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
BIO's comments regarding FDA's Guidance
May 7, 2003
May 7 2003
PDUFA Final Goals
June 4, 2002
Letter from HHS Secretary Tommy Thompson
June 4 2002
Reauthorization of the Prescription Drug User Fee Act
March 6, 2002
Mr. Chairman and Members of the Subcommittee, I am Mary K. Pendergast, Executive Vice President for Government Affairs at Elan...
March 6 2002
FDA Stakeholders Meeting
December 7, 2001
Good morning. My name is Michael Werner. I am Vice President for Bioethics for the Biotechnology Industry Organization (BIO). BIO...
December 7 2001

Letters, Testimony & Comments

SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
FDA Public Meeting: Approval Pathway for Biosimilar and Interchangeable Biological Products
May 11 2012
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...
BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements
March 29 2012
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
Good Guidance Practices: FDA Report on Good Guidance Practices: Improving Efficiency and Transparency
February 29 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on...
BIO Statement to the Presidential Commission for the Study of Bioethical Issues: Principles Regarding Ethical Performance of International Clinical Trials
November 16 2011
Given by Russell M. Medford, MD, PhD President and CEO, Salutria Pharmaceuticals, LLC BIO Board Standing Committee on Bioethics Co-...
More Letters, Testimony & Comments →

Press Releases

2012 BIO International Convention to Highlight the FDA and Regulatory Environment
May 9 2012
WASHINGTON, DC – (May 9, 2012) – The U.S. regulatory environment strongly impacts innovation and the...
Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO
February 9 2012
Patient Safety Must Remain Top Priority Washington, D.C. (February 9, 2012) — Biotechnology Industry...
New Study Shows the Rate of Drug Approvals Lower than Previously Reported
February 14 2011
WASHINGTON, D.C. (Monday, February 14, 2011) - Biotechnology Industry Organization (BIO) Industry Analysis and ...
BIO Celebrates Senate Passage of PDUFA Reauthorization Package
September 21 2007
WASHINGTON, D.C. (September 21, 2007) -- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood...
BIO Commends House for Approving PDUFA Reauthorization Package
September 19 2007
WASHINGTON, D.C. (September 19, 2007) -- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood...
More Press Releases →