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Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section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?

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.