Regulatory Affairs

Patent systems can provide an advantage to society by rewarding the development of new inventions, promoting the advancement of technology and protecting the investor.  Patents often are the most important, and sometimes only, asset of a biotech company. Patents and related rights must be obtained in a timely and predictable manner and the ability to enforce those patents is critical.

The Massachusetts Life Sciences Center, which is tasked with administering the $1 billion state's life sciences initiative, has awarded five loans to start up companies, totaling $3.75 million.

Overhauled BIOTradeStatus lets users search for the latest information on hundreds of products.

Budget victories will help biotechnology in the Commonwealth

The Patent Reform Act of 2011 would strengthen and improve our nation’s patent system, spurring innovation and job creation.

Industry leaders point out that biotech-enabled advanced biofuels spur job growth and reduce U.S. dependence on imported oil.

The government’s Qualifying Therapeutic Discovery Project Program is doing what it was intended to do, according to a recent survey of senior executives at small biotechnology companies.

Scientific American will release the third annual Worldview: A Global Biotechnology Perspective at this year’s BIO International Convention.  Created in partnership with BIO, the publication explores the diverse economic regions of the world, highlighting success stories, policy achievements, cutting-edge science and the unique challenges that lie ahead. This year’s report focuses on BRIC (Brazil, Russia, India and China) country efforts to build local biotechnology hubs. 

Agency issues partial deregulation of Roundup Ready sugar beets while it prepares an environmental impact statement.

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Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section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

Letters, Testimony & Comments

February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
February 4 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
January 24 2013
Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are...
January 24 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,...

Press Releases

January 23 2013
Washington, D.C. (January 23, 2013) –  The Biotechnology Industry Organization (BIO) announced that Ken...
October 9 2012
Any waiver of the RFS would have little to no effect on corn prices, but would certainly harm biofuel producers and...
February 9 2012
Patient Safety Must Remain Top Priority Washington, D.C. (February 9, 2012) — Biotechnology Industry...
September 16 2011
Washington, D.C. (September 16, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
September 1 2011
WASHINGTON, D.C.(Sept. 1, 2011) – Research and development in synthetic biology is an evolution of...