FDA Review

August 2, 2011

The biotech industry has shrunk dramatically in recent years based primarily on the continued...

May 13, 2011

Multiple sclerosis (MS) is a complex disease involving immune-system attacks on the central...

May 4, 2011

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of...

April 11, 2011

Current rules resulting from a 2003 Office of Hearings and Appeals decision have inhibited and...

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BIO thanks the Food and Drug Administration for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format .”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BIO thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance for Industry on Electronic Source Data in Clinical Investigations.”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.