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PDUFA

FY2011 Innovative Treatment Approvals
November 3, 2011

BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for...

PDUFA V Recommendations Promote Development of Innovative Therapies
November 3, 2011

Underlying the PDUFA V recommendations are the principles that a science-based, transparent,...

Countdown to Partnering - John Carroll, Editor of Fierce Biotech
April 7, 2011

 John Carroll, editor of Fierce Biotech, shares what he won't miss at the 2011 BIO...

The Reimbursement Landscape for Novel Diagnostics: Current Limitations.
January 6, 2011

Personalized medicine has the potential to revolutionize patient care. The fundamental goal in...

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Letters, Testimony & Comments

PDUFA V: Testimony to House Committee on Energy and Commerce, Subcommittee on Health
February 1 2012
  Chairmen Upton and Pitts, and Ranking Members Waxman and Pallone, it is my privilege to provide testimony before this...
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...
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...
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...
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...
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Press Releases

BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations
February 1 2012
Washington, D.C. (February 1, 2012) – Richard Pops, Chairman and CEO of Alkermes plc, testified today on behalf...
BIO Urges Congress to Promptly Reauthorize PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
January 13 2012
Washington, DC (January 13, 2012)- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released...
BIO Expresses Strong Support for Timely Reauthorization of PDUFA
October 24 2011
Washington, D.C. (October 24, 2011) – The Biotechnology Industry Organization (BIO) provided a statement of...
BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
September 1 2011
Washington, D.C. (September 1, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
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...
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