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Andrew Emmett on PDUFA and the 2012 BIO International Convention
April 12, 2012

Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important...

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...

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Letters, Testimony & Comments

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...
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"
April 18 2012
Chairman Upton and Pitts, Ranking Member Waxman and Pallone, Members of the Committee, it is my privilege to provide testimony before you...
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...
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...
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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...
BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA
March 29 2012
Washington, D.C. (March 29, 2012) – Sara Radcliffe, Executive Vice President of Health at the Biotechnology...
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...
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