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Press Releases

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...

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 Statement on “Food Labeling” Petition to FDA
October 4 2011

A coalition of anti-technology groups under the moniker “Just Label It” has...

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...

Hill Leadership: Support Science-Based Assessments by FDA
August 3 2011

Animal Agriculture Coalition Members denounce political interference in FDA process.

Stem Cell Ruling Will Enable Critical Research to Move Forward Toward Cures and Breakthrough Medicines
July 27 2011

BIO praised today’s ruling by a U.S. District Court dismissing a lawsuit that sought to...

BIO Unveils Strategic Initiative to Speed Scientific Breakthroughs, Develop Cures and Grow the Bio-Economy
June 29 2011

“Unleashing the Promise of Biotechnology: Advancing American Innovation to Cure Disease...

BIO Statement on House Amendment to Block Funding for FDA Approval of GE Salmon
June 16 2011

An amendment offered on the House floor last night would ban the FDA from using any funding to...

FDA Sets VMAC Meeting to Consider Genetically Engineered Salmon
August 26 2010

Genetically engineered (GE) animals have already realized the promise of advancing human...

FDA Commissioner to Speak at 2010 BIO International Convention
March 22 2010

U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg will be a featured...

BIO Congratulates Dr. Margaret Hamburg for Nomination to Lead FDA and Dr. Joshua Sharfstein for Appointment as Deputy Commissioner
March 15 2009

BIO President and CEO Jim Greenwood released the following statement today commending President...

BIO Commends House for Approving PDUFA Reauthorization Package
September 19 2007

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

BIO and 21 Patient Groups Issue Letter Supporting FDA’s Critical Path Initiative
January 13 2006
BIO STATEMENT ON FDA COMMISSIONER
October 18 2002

Letters, Testimony & Comments

Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 27 2013
Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
February 19 2013
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
Data Standards: BIO Comments on Development of Prioritized Therapeutic Data
January 22 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Development of Prioritized Therapeutic Data Standards (the Notice).”
IRB: BIO Comments on Draft Guidance for IRBs
January 22 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for IRBs, Clinical Investigators, and Sponsors."
More Letters, Testimony & Comments →

Press Releases

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 released U.S. Food and Drug Administration (FDA) guidance for the review and approval of biosimilars.
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 need for a quick reauthorization of the Prescription Drug User Fee Act (PDUFA) and enactment of the enhancements recommended in the PDUFA V agreement. 
BIO Statement on “Food Labeling” Petition to FDA
October 4 2011
A coalition of anti-technology groups under the moniker “Just Label It” has reportedlysubmitted a petition to the U.S. Food and Drug Administration (FDA) calling for the mandatory labeling of foods that have been grown using agricultural biotechnology.
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 following statement on the Prescription Drug User Fee Act (PDUFA) V recommendations as published by the U.S. Food and Drug Administration (FDA).
Hill Leadership: Support Science-Based Assessments by FDA
August 3 2011
Animal Agriculture Coalition Members denounce political interference in FDA process.
More Press Releases →