FDA Review

Multiple sclerosis (MS) is a complex disease involving immune-system attacks on the central nervous system. Research into MS involves questions that dovetail many fields of science, including immunology, neuroscience, psychology and more.

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of leading biotechnology companies shows that clinical development times – specifically the duration of Phase II and Phase III trials – are lengthening, while FDA review times have remained constant.

Current rules resulting from a 2003 Office of Hearings and Appeals decision have inhibited and interfered with the growth and survival of small private biotechnology companies and the development of promising technologies and products

President’s call for more funding comes as Congress focuses on reducing budget deficits.

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?

On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA) with respect to a biotechnology product that relies, directly or indirectly, on trade secret and confidential commercial data and information of an innovator.

Biotechnology is all around us and is already a big part of our lives, providing breakthrough products and technologies to combat disease, reduce our environmental footprint, feed the hungry, and make useful products.

Disease resistant animals, environmentally friendly livestock, pharmaceuticals produced by goats - are these really possible?

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. 

We have used the biological processes of microorganisms for 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products.

Today, the biotechnology industry is enjoying more success and influence than ever before. Our industry’s innovations continue to improve the lives of people worldwide, and the advancement of these innovations is supported by the work of BIO.

Has a member of your family been vaccinated against hepatitis B? Do you know someone who has diabetes? Has anyone in your family had heart disease?

Letters, Testimony & Comments

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).
July 15 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.”

Press Releases

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). 
March 6 2015
Washington, D.C. (March 6, 2015) – The Biotechnology Industry Organization (BIO) issued the following statement today regarding the approval by the Food and Drug Administration (FDA) of the first biosimilar product under the pathway created by the Biologics Price Competition and Innovation Act (BPCIA).
February 25 2015
Washington, D.C. (February 25, 2015) – The Biotechnology Industry Organization (BIO) today applauds Representatives Leonard Lance (R-NJ) and Anna Eshoo (D-CA) for introducing the FDA Safety Over Sequestration Act, or FDA SOS Act. The Act would exempt privately-paid user fees paid to the FDA from any future operation of sequestration.  
February 5 2015
Washington, D.C. (February 5, 2015) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding the announced retirement of Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg: