Press Releases

January 9 2014

Nature Biotechnology published ...

December 13 2013

BIO applauds the House of Representatives for passing a bipartisan budget deal, which raises...

December 12 2013

Hastings highlighted the need to advance the regulatory environment so that it fosters...

July 29 2013

BIO released a statement in support of the FDA Safety Over Sequestration Act (H.R. 2725), which...

May 9 2012

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

February 9 2012

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

February 14 2011

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

September 21 2007

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

September 19 2007

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

January 11 2007

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

May 22 2002

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

September 16 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments in response to its 2-day public meeting “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies.”  
August 26 2013
BIO fully supported the expansion and modernization of FDA’s Accelerated Approval pathway and the enactment of the new Breakthrough Therapy Designation Process under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA, P.L. 112-144).
July 16 2013
 The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Center for Drug Evaluation and Research Medical Policy Council; Request for Comments.”
May 8 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format .”
March 26 2013
BIO thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance for Industry on Electronic Source Data in Clinical Investigations.”
August 6 2014
Survey responses will help inform Prescription Drug User Fee Act VI negotiations
January 9 2014
Nature Biotechnology published a peer-reviewed paper co-authored by the BIO Industry Analysis and BioMedTracker (BMT) highlighting results of a study showing that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2011 is near one in 10.
December 13 2013
BIO applauds the House of Representatives for passing a bipartisan budget deal, which raises discretionary budget caps, which should provide the Food and Drug Administration  with complete access to its user fees for FYs '14 and '15. 
December 12 2013
Hastings highlighted the need to advance the regulatory environment so that it fosters biopharma innovation. Among his recommendations, Hastings emphasized the need to eliminate the sequestration of industry user fees and expedite drug development for serious and life-threatening diseases by expanding the existing Accelerated Approval pathway and by facilitating the new Breakthrough Therapy Designation process.
July 29 2013
BIO released a statement in support of the FDA Safety Over Sequestration Act (H.R. 2725), which would exempt user fees, including those paid by BIO member companies, from the operation of sequestration.