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Letters, Testimony & Comments

SMU: BIO Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
March 1 2013
PDUFA V: BIO Comments on FDA's NME Review Program Assessment
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
August 5 2012
BIO's Letter of Support for Passage of H.R. 5651, Food and Drug Administration Reform Act of 2012
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express...
May 30 2012
BIO's Suppport for the Reauthorization of the Prescription Drug User Fee Act (PDUFA V)
    Dear Chairman Upton and Ranking Member Waxman: On behalf of the Biotechnology Industry Organization (BIO), I am...
May 10 2012
BIO Endorsement Letter for the Senate Health, Education, Labor and Pensions Committee Markup of the Food and Drug Administration Safety and Innovation Act (FDASIA)
      On behalf of the Biotechnology Industry Organization (BIO), I am writing to express support for the Food...
May 2 2012
BIO's Testimony to the April 18, 2012 House Committee on Energy and Commerce, Subcommittee on Health Hearing on "FDA User Fees 2012: How Innovation Helps Patients and Jobs"
Chairman Upton and Pitts, Ranking Member Waxman and Pallone, Members of the Committee, it is my privilege to provide testimony before you...
April 18 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
PDUFA V: Testimony to House Committee on Energy and Commerce, Subcommittee on Health
  Chairmen Upton and Pitts, and Ranking Members Waxman and Pallone, it is my privilege to provide testimony before this...
February 1 2012
PDUFA V: BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
  On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment on the reauthorization of the...
October 24 2011
BIO’s Comments on the Internal Revenue Service's (IRS) Proposed Guidance Regarding the Branded Prescription Drug Fee
June 15, 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry...
June 15 2011
Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period
August 13, 2010
BIO recently submitted written comments to the FDA on the impact of Risk Evaluation and Mitigation Strategies (REMS) on the healthcare...
August 13 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
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 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
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 Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need
March 1 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
PDUFA V: BIO Comments on FDA's NME Review Program Assessment
August 5 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
BIO's Letter of Support for Passage of H.R. 5651, Food and Drug Administration Reform Act of 2012
May 30 2012
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express...
BIO's Suppport for the Reauthorization of the Prescription Drug User Fee Act (PDUFA V)
May 10 2012
    Dear Chairman Upton and Ranking Member Waxman: On behalf of the Biotechnology Industry Organization (BIO), I am...
BIO Endorsement Letter for the Senate Health, Education, Labor and Pensions Committee Markup of the Food and Drug Administration Safety and Innovation Act (FDASIA)
May 2 2012
      On behalf of the Biotechnology Industry Organization (BIO), I am writing to express support for the Food...
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Press Releases

PDUFA V Sets New Course for Regulatory Science – Joint BIO/PhRMA Statement
October 1 2012
Washington, D.C. (October 1, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and...
BIO Commends Senate for Approval of User Fee Package
June 27 2012
FDASIA headed to President for signature into law Washington, D.C. (June 26, 2012) –Biotechnology Industry...
BIO Hails House Passage of Reconciled User Fee Package
June 21 2012
  Washington, D.C. (June 21, 2012) –Biotechnology Industry Organization (BIO) President and CEO Jim...
BIO Lauds Senate Passage of User Fee Package
May 24 2012
Washington, D.C. (May 24, 2012) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood...
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...
More Press Releases →