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Press Releases

PDUFA V Sets New Course for Regulatory Science – Joint BIO/PhRMA Statement
October 1 2012

Pharmaceutical Research and Manufacturers of America PhRMA President and CEO John J....

BIO Commends Senate for Approval of User Fee Package
June 27 2012

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the...

BIO Hails House Passage of Reconciled User Fee Package
June 21 2012

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the...

BIO Lauds Senate Passage of User Fee Package
May 24 2012

BIO commends the bipartisan Senate approval of FDASIA, which includes a reauthorization of the...

2012 BIO International Convention to Highlight the FDA and Regulatory Environment
May 9 2012

Global event for biotechnology to be held June 18-21, 2012 in Boston.

BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA
March 29 2012

Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization...

BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations
February 1 2012

In the testimony, Richard Pops, Alkermes plc Chairman and CEO,  stressed the...

BIO Urges Congress to Promptly Reauthorize PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
January 13 2012

BIO strongly supports the PDUFA V recommendations as they will enhance the drug development...

BIO Expresses Strong Support for Timely Reauthorization of PDUFA
October 24 2011

In a public meeting hosted by FDA, BIO  expressed strong support for the PDUFA V...

BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
September 1 2011

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the...

BIO Celebrates Senate Passage of PDUFA Reauthorization Package
September 21 2007

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the...

BIO Commends House for Approving PDUFA Reauthorization Package
September 19 2007

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the...

Recommended Improvements to Prescription Drug User Fee Program Will Improve Drug Safety
January 11 2007

The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by...

House Passes Bioterrorism/PDUFA Legislation in 425-1 Vote
May 22 2002

The House of Representatives today voted 425-1 to approve “The Public Health Security...

BIO President Addresses FDA on PDUFA
September 18 2000

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...
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