Regulatory Affairs

BIO will be co-hosting an event with the United States Patent and Trademark Office (USPTO) to celebrate the 30th anniversary of the issuance of U.S. patent 4,259,444 to Ananda Chakrabarty following the Supreme Court case, Diamond v. Chakrabarty, which held that Chakrabarty’s bioengineered bacterium was eligible for patenting.

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.

Mark Herzog, executive director of the Virginia Biotechnology Association recently discussed the success and challenges facing the burgeoning bioscience industry in his state.

"The Value Proposition for Cellulosic and Advanced Biofuels Under the Federal Renewable Fuel Standard" is forthcoming in the April 2011 Industrial Biotechnology Journal.

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

The Agriculture Department has announced additional money for loan guarantees to support construction of new advanced biofuel biorefineries.

The Maryland initiative’s 10-year plan helps build biotech access to funding

BIOtechNOW talks to GEN's John Sterling regarding the upcoming BIO International Convention.

GEN's Editor-in-Chief John Sterling outlines his picks for the top ten "must attend" breakout sessions at the 2011 BIO International Convention.

As we celebrate World Health Day today, it is an opportunity to remember that vaccines represent one of the most important global health investments.

 John Carroll, editor of Fierce Biotech, shares what he won't miss at the 2011 BIO International Convention.

Fifteen years after Dolly, the first mammal to be cloned from an adult cell rather than an embryo, made headlines, the process of livestock cloning is increasingly gaining acceptance as a viable means of satisfying demand for sustainable food production.

Derek Gregg discusses biotech in WV – major growth areas, outlook for the future, and upcoming plans for the BIO International Convention.

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...