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Press Releases

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.

Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO
February 9 2012

BIO President and CEO Jim Greenwood issued the following statement regarding the newly...

New Study Shows the Rate of Drug Approvals Lower than Previously Reported
February 14 2011

Biotechnology Industry Organization (BIO) Industry Analysis and  BioMedTracker (BMT)...

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
BIO Looks Forward to Implementation of FDA Reforms
November 21 1997
BIO Calls on President Clinton to Sign FDA Reform Bill Into Law
November 10 1997
BIO lauds House of Representatives for "Moving FDA in New Direction" with passage of H.R. 1411
November 7 1997

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 →