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...

Letters, Testimony & Comments

February 8 2016
BIO strongly supports the Prescription Drug User Fee Act (PDUFA 5) program to enhance FDA-Sponsor communication, which is based on FDA’s stated philosophy that “timely interactive communication with Sponsors during drug development is a core activity to help achieve our mission to facilitate the conduct of efficient and effective drug development programs, which can enhance public health by making new safe and effective drugs available to the American public in a timely manner.” BIO applauds FDA’s effort to give IND Sponsors and FDA review staff best practices and procedures for timely, transparent, and effective communications during drug development through this Draft Guidance.
June 23 2015
The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) submit these comments in response to the Federal Register notice entitled “Interim Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket” issued by the U.S. Food and Drug Administration (FDA).
December 29 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on “Best Practices for Communication Between the Food and Drug Administration and Investigational New Drug Sponsors During Drug Development.”
September 15 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 25 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).

Press Releases

April 6 2016
Washington, D.C. (April 6, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding today’s Senate HELP Committee mark-up of legislation as part of the Senate biomedical innovation initiative:
March 17 2016
Washington, D.C. (March 17, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the introduction today by Senators Alexander and Murray of the FDA and NIH Workforce Authorities Modernization Act:
February 24 2016
“BIO extends our congratulations to Dr. Califf on his confirmation as Commissioner of the FDA, a job that carries tremendous responsibility in protecting public health and advancing biotechnology innovation. 
April 29 2015
Washington, D.C. (April 29, 2015) – The Biotechnology Industry Organization (BIO) today releases the following statement on the 21st Century Cures Initiative discussion draft shared by Chairman Fred Upton (R-MI), Rep. Diana DeGette (D-CO), Rep. Frank Pallone, Jr. (D-NJ), Rep. Joe Pitts (R-PA), and Rep. Gene Green (D-TX).